November 2, 2011
According to a recent Wall Street Journal piece, pets who rely on drugs approved for people are likely to suffer now that nearly 200 of these are in short supply. This news is according to the American Society of Health-System Pharmacists.
Only a fraction of the drugs we veterinary professionals use on our patients are actually approved for use in veterinary settings. That’s mostly because it’s expensive to get drugs approved for specific indications in specific species (as the FDA requires for each individual drug).
Luckily, the federal government has made exceptions for extra-label drug use that conform to the standard of care (as of the late 1990s).
When a critical mass of us have deemed a certain drug for a certain species at a certain dosage useful in the treatment of a certain disease, then this product is henceforth legally acceptable to implement in routine practice, even though it has not gone through the traditional approval process.
But this extra-label “exemption,” if you will, is also why the veterinary industry has come to rely on human preparations of a great many drugs that affect our daily lives. Everything from commonplace OTC products like famotidine and diphenhydramine to the most esoteric chemotherapeutics are instrumental in our clinical success.
So it is that when humans suffer drug shortages, we experience them even more acutely. After all, people come first when it comes to distributing drugs, which is why (if you’re like me) you may be stressed out over discontinued drugs, indefinite backorders and unexpected recalls.
Though human product recalls and shortages have been in the news lately, animal-specific drug issues have served as a leading indicator for more than a year now.
For example, Immiticide is unavailable (for months as of press time) due to a manufacturing issue. Our popofol supply is testy. And lots of other ancillary meds are obnoxiously fickle when it comes to their expected supply.
And I mean lots.
So, OK, it’s not enough that upwards of 200 human drugs are largely unavailable to us; now our own dedicated animal drug manufacturers are leaving us in the lurch. Still, it’s the human drugs we mostly rely on. And—predictably, perhaps—we’re last in line to gain access to these drugs. Which only makes sense.
But here’s the big question: Why has this been happening?
According to the Institute for Safe Medication Practices, which last year called the shortages of key human drugs “unprecedented,” drugs become scarce for a variety of reasons, including the unavailability of raw ingredients, FDA enforcement actions that halt production, voluntary recalls, poor inventory ordering, a change in product formulation and even rumors of an impending shortage, which can cause hoarding.
Ah, hoarding … it happens in all circles. But should you be worried for your patients?
Mostly … Not so much. After all, more than 99 percent of the drugs we lack are those not approved in vet medicine because they’re not terribly common. The downside is that these drugs we lack are those veterinarians use in times of serious crisis. Consider:
Vets reported shortages of doxorubicin, a chemo drug used to treat different cancers in humans and pets, and of another oncology drug, mechlorethamine hydrochloride (brand name Mustargen). The latter is a “rescue” therapy for lymphoma used when other drugs don’t work in people and pets.
“When it’s not available, that limits the little bag of tricks” we reach into, says Kristine Burgess, a veterinary oncologist at the Foster Hospital for Small Animals at Cummings School of Veterinary Medicine at Tufts University. Not offering it “is denying your pet a really good drug.”
So sad that so many pets are going without. And yet, it’s even more sad to hear that all of us are missing out.
Given the table I’ve set, here’s the inevitable question: What is it about modern manufacturing processes that these behemothic pharmaceutical companies haven’t yet come to understand about producing chemicals and biologicals on a global scale?
How can it be that they’ve gone so inept at keeping pace with basic supply and demand?
Call me cynical, but somehow it seems to me as if there are certain industries that have recently shown they’re not best built for globalization and oligopoly—especially when they have obviously not lived up to their blustery promises of greater efficiency and seamless supply.
If anything, our reliance on their ginormity and outsized global reach has proven overblown and altogether unfounded.
So it is that we sit and wait for our drugs. While our patients die … and big pharma plays its ticker tape-driven game of thrones.
Dr. Khuly is a mixed-animal practitioner in Miami and a passionate blogger at Vetstreet.com. She earned her veterinary degree at the University of Pennsylvania and MBA at Wharton School.
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