This sad story harkens back to my days as a pharmacy prof when students would argue for points on an incorrect pharmaceutical calculations exam by saying, “well, only the decimal point was off.”
A pharmacy erroneously made a drug 10 times more potent than intended, which killed three people who received it at an Oregon clinic, the state medical examiner said Friday.
ApotheCure Inc., a drug compounding pharmacy company in Texas, said an employee made a weighing error in the creation of the drug colchicine.
Drug compounding pharmacies have often attracted controversy. While they fulfill the classical Rockwellian pharmacist’s role of making drug formulations to order, particularly ointments or suppositories, they have often come under FDA scrutiny for making unapproved drug formulations, especially hormones and obsolete drugs. Regular readers will recall that a Canadian compounding pharmacist was recently asked to stop selling his formulation of an investigational cancer drug, dichloroacetate (DCA).
There are quite a few odd issues in this story, not the least of which is that three people died over the course of weeks from an unconventional use of the natural product drug, colchicine. Dervied from the Colchicum species of meadow saffron, this alkaloid inhibits microtubule polymerization and neutrophil motility. Although it acts in a manner similar to some anticancer drugs, its most prevalent use has been to treat gout.
The drug was only sent to the Center for Integrative Medicine in Portland, where three people received injections of the defective batch to treat back pain, ApotheCure said.
As pointed out by PharmGirl, MD, who tipped me on this story, injectable colchicine is not a standard practice for back pain. So much for integrative medicine being more “natural” and less invasive than conventional medical practice.
Even more appalling was the response from one of the ApotheCure pharmacists:
“We are kind of the leaders in the industry,” Osborn said. “But you know what people say, stuff happens.”
Leaders in the industry? Three deaths from an unconventional use of a drug due to a ten-fold dosing error and the defense is “stuff happens?” I cannot imagine a context in the course of a reporter’s interview where this quote would’ve been appropriate. And surely the mistake might have been caught after the first, and certainly the second, death.
So, yes, pharmacy students…the decimal point matters.
Addendum (2 May 2007): The US FDA MedWatch program has issued a manufacturer recall for the injectable colchicine product produced by this compounding pharmacy.