Drug Shortage Frustration – The Reasons For Your Pain
Aminophylline, lidocaine, procainamide, doxorubicin, epinephrine, cisplatin, naloxone, furosemide, acepromazine, furosemide, vincristine, melarsomine (for heartworms), buprenorphine, diazepam, fentanyl, propofol, insulin, cytoxan, and many more…
I suspect most vets in the country have been frustrated by the drug shortages we have been enduring for the past few years.
The reason for our collective pain is what I’ve been trying to understand, but I have yet to read a satisfying explanation.
The most common one I’ve heard? “There is only one manufacturer for this generic drug, and they ran out of the active ingredient.”
This explanation sounds totally fishy to me. How can I believe that there is only one facility that can make atropine or diazepam in the universe? How can a manufacturer, arguably not new to the business scene and not interested in losing money, be clueless enough to run out of the ingredient that (s)he depends on, and that countless physicians, veterinarians and patients depend on?
No, that explanation was not satisfactory to me at all.
Turns out I was right, according to our good friends at the FDA.
They studied 127 incidents of human drug shortages between January 1, 2010, and August 26, 2011. Shortage of active ingredient was only implicated in 10 percent of the cases. Here are the primary reasons found:
• 43 percent – problems at the facility
• 15 percent – delays in manufacturing or shipping
• 10 percent – shortage of active ingredient
• 9 percent – unknown
• 8 percent – business decision (discontinuation etc.)
• 5 percent – loss of manufacturing site
• 4 percent – demand increase
• 4 percent – shortage of non-active ingredient
• 2 percent – improper labeling
Certainly, some of these reasons have to do with issues at the factory level that do not affect drug quality or safety. In these days of wild mergers and acquisitions, it’s not difficult to imagine that a not-so-profitable drug, especially for a market as small as the veterinary world, may be dropped altogether. It sucks, but it’s a business decision.
If “everybody” starts to use “MLK CRIs” (Morphine – Lidocaine – Ketamine Continuous Rate Infusions), maybe, just maybe the demand is high enough that manufacturers can’t keep up. Then again, the day all patients benefit from a CRI is not around the corner…
And then there are silly mistakes or problems such improper labeling, packaging supply deficiencies, shortages of non-active ingredient, etc.
So there you go, now you know the reasons for the frustration. There is no perfect solution to this problem. One option may be to be open-minded and flexible enough to avoid using the same recipe in all patients, and investigate alternative options which will be useful, if not life-saving, when the day comes.
Dr. Phil Zeltzman is a mobile, board-certified surgeon in Allentown, Pa. His website is www.DrPhilZeltzman.com. He is the co-author of “Walk a Hound, Lose a Pound: How You and Your Dog Can Lose Weight, Stay Fit, and Have Fun Together.”