Earlier this week, CIDRAP news writers highlighted an overlooked fact: even before the current multistate fungal meningitis outbreak, safety problems with products from compounding pharmacies had led to at least 23 deaths and 86 serious illnesses or injuries in 34 states over the past decade.
Now, the recent fungal meningitis outbreak links 300 documented cases and 25 deaths to contaminated steroid injections traced back to the Framingham, MA compounding pharmacy New England Compounding Center (NECC).
As has been widely reported, it appears NECC wasn’t following crucial sterilization procedures. Their pharmacists in some occasions weren’t allowing even the minimum amount of time needed to confirm that a batch of medication was sterile.
The pharmacy also didn’t properly test its own sterilization equipment, and when it sent batches of drugs to an outside lab for sterility testing, it didn’t wait for the results to come back before shipping medication from the same lot to patients or physicians. In a sense – they had no idea if the medication was safe before it was shipped.
The situation begs the question: how did this happen?
Compounding pharmacies are different than drug manufacturers and are largely not regulated by the Food and Drug Administration (FDA). Instead, they’re overseen by state pharmacy boards or state health departments. Compounded products are replications of FDA-approved drugs made by pharmacists, but they themselves are not approved since their formulation or content differs from their FDA-approved counterparts.
According to University of Minnesota School of Public Health infectious disease expert Michael Osterholm, Ph.D., M.P.H., the outbreak “should be a wakeup call to the public health and medical communities, regulators and the general public that the medical care systems still represent a place where bad things can happen to people, including life threatening infections, when there is a lack of oversight with the production of drugs and medical devices.”
Osterholm added that there are many unanswered questions about how to assess and follow a patient’s injectable drugs from a company: How did it arrive at the doctor’s office? Was it from a manufacturer or a compounding company?
If a drug comes from a manufacturer, there is a greater likelihood it has been appropriately regulated. In the case of compounded pharmacies – which rely primarily on professional judgment, not on FDA regulations – there are real concerns about safety and efficacy.
“These fungal infections represent very real carelessness that is impossible to undo and now difficult to treat,” said Osterholm. “In an age when we keep hearing there is too much regulation, we have to be mindful of what happens when we don’t have enough. This should make its case in spades.”
Why would anyone choose to use a compounding pharmacy like the one involved in this outbreak?
The fungal meningitis outbreak is being investigated by the Centers for Disease Control and Prevention (CDC) in collaboration with state and local health departments and the Food and Drug Administration (FDA).
CDC and public health officials are referring any patients who have symptoms that suggest possible fungal infection to their physicians, who can evaluate them further. Patients who received injections in peripheral joints only are not believed to be at risk for meningitis, but they could be at risk for joint infection.