While the outbreak of meningitis that has killed 14 and sickened 170 in the U.S. is being blamed on contamination problems at a Massachusetts pharmacy, the bigger cause is a global drug shortage, says an expert on the matter.
Dr. Jacalyn Duffin, a hematologist and a medical historian at Queen's University, says while this outbreak has been confined to the U.S., it is possible that something similar could happen here in Canada.
“We need to be concerned about it because the reason this has happened relates to a much bigger, deeper problem that is global in its scope. And that is a shortage of generic drugs,” she told CTV’s Canada AM Friday from Kingston, Ont.
All of those infected in the U.S. have developed a fungal form of meningitis after receiving contaminated steroid injections into their spines and other joints, according to the U.S. Centers for Disease Control and Prevention.
The patients received their medications from a specialty compounding pharmacy in Massachusetts, called the New England Compounding Center. Fungus has been found in at least 50 vials of an injectable steroid medication made there.
The outbreak has shone the spotlight on compounding pharmacies and their role in the drug supply. These pharmacies mix solutions and creams that can be customized to patients. They can mix smaller medication doses, or change a formulation, turning pills into liquids, for example.
While they're supposed to produce medication for patient-specific prescriptions, Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health says it appears the company violated state law and moved into large-scale medication production.
The company has recalled the suspect product and surrendered its operating licence.
The problem is that unlike larger drug manufacturers, the products from the pharmacy didn’t need to be approved by the Food and Drug Administration.
It’s still not clear what went wrong in this case, but it appears that at some point, the injectable pain relievers become contaminated with fungus.
Duffin says the drug these patients needed was in short supply, which is why suppliers had to turn to compounding pharmacies in the first place. She says such a shortage could happen here in Canada too, but it’s not clear whether we would turn to compounding pharmacies as well.
“I do not know if we in Canada are allowed to do that, if that is a stop-gap measure that is available to us. It’s a question we should be asking Health Canada,” she said.
Duffin added that if Canadian companies did turn to compounding pharmacies, then perhaps we too would be vulnerable.
“I think however that most of the drugs that are licensed in Canada by Health Canada are very carefully inspected. Viewers should not be feeling a panic about that,” she added.
“The bigger question is when something goes missing, we do look for substitutes. And when you start looking for substitutes on short notice, then we are vulnerable to problems.”
