Meningitis is quickly becoming fall’s freaky health scare, but the cause–custom mixed drugs sold by compound pharmacies–isn’t a temporary anomaly. In this case, a custom mix of steroids used to treat patient back pain appears to have been contaminated with a fungus that, so far, has caused at least 35 cases of meningitis and five deaths. The meningitis is scary, but even more shocking to me was the fact that these pharmacies mixing up custom drug combos are legal–because even if they are using real, approved drugs, compound pharmacies don’t sound all that far off from the woman who was sent to jail for injecting cement and tire sealant into patients’ buttocks.
If you don’t know what compound pharmacies are (I didn’t), they’re basically places that mix up existing drugs to create new formulas that aren’t otherwise on the market. So, if you need hormone treatment but would prefer an ointment to a pill, they can do that. It can be great for patients who need to avoid a non-essential ingredient for allergy reasons…or it can be great for patients who’d prefer lemon-flavored medicine to cherry.
Except that not all prescription drugs are super safe, so it’s not actually all that great that these places are allowed to mix and match without approval of the final product from the Food and Drug Administration.
To be fair, the FDA has been trying to crack down on compound pharmacies (and health scares like this one are likely to help their case), but still: As this meningitis scare goes to show, compound pharmacies are risky business.
Compound pharmacies aren’t quite as scary as a fake plastic surgeon injecting fix-a-flat into patients’ bodies–after all, they’re using actual drugs (not tire sealant), and they’re not trying to make a buck off of patients’ cosmetic concerns. Forbes also points out that compound pharmacies deserve credit for bringing down health care costs, too; in many cases, they’re able to offer drugs that cost much less than brand-name, FDA-approved drugs with similar functions. And, in many cases, their formulas are just as effective and safe.
Except when they’re not. And, since their drugs aren’t strictly overseen and regulated by the FDA, patients end up assuming the risks, and suffering the consequences when the drugs don’t have desired effects.
Currently, an estimated 2 to 3% of all prescriptions in the U.S. are for specialty compound prescriptions. Regulation is limited to ensuring that compound pharmacies don’t mass produce drugs–since their primary purpose is supposed to be tailoring prescriptions to individual patient needs–but the pharmacy responsible for the current meningitis outbreak shipped 7,676 vials of their solution to 75 clinics in 23 states. Which seems like a fairly large lot of custom-mixed painkiller.
And this isn’t the first time that compound pharmaceuticals have caused serious illness and death. The New York Times outlines several recent outbreaks caused by contaminated drugs, including cases where the pharmacies had a clear lack of safety checks, and questionable sterile processing capabilities.
It’s unclear whether laws protect patients (or doctors) who assume the risk of their custom-mixed drugs, but if health care costs have gotten to the point where patients need to save money by using potentially unsafe drugs, I think we’re all in trouble.
Photo: flickr user stevendepolo