You may have read in The Inquirer about a health professional alert that FDA sent last week about potential injury due to look-alike/sound-alike drug name confusion between the FDA-approved eye medicine Durezol and an FDA-unapproved prescription wart remover called Durasal, which is salicylic acid 26%. Obviously, about the last thing you want to put into your eye would be any sort of acid. But that’s already happened at least once, and it resulted in a man’s grievous eye injury, which led to a $1 million lawsuit against a pharmacy where the mix-up occurred.
You might wonder how or why someone would put Durasal in their eye instead of Durezol eye drops, especially when there’s a warning against it on the label and the containers don’t look alike. But keep in mind that Durezol is used after eye surgery when patients have problems seeing, which is why they’re supposed to be using eye drops!
I wrote about confusion between Durezol and Durasal this past September after receiving several complaints from pharmacists and nurses about the potential for mix-ups. Actually, we first reported this problem to FDA in 2009 and also alerted the pharmacy community but reports from health professionals have continued coming to us through our medication error reporting program. I’m very thankful for FDA’s alert, which received a massive amount of media coverage, including major TV networks like ABC TV. No doubt the publicity will make many more people aware of the potential for problems with these medications.
FDA has never formally approved Durasal, whose main ingredient, salicylic acid, has been around long before the 1938 Food, Drug, and Cosmetic Act, and thus was “grandfathered.” FDA was also unaware of the name Durasal at the time that Durezol eye drops were going through the approval process, since it hadn’t yet been used for this particular salicylic acid product.
As I mentioned in my earlier blog, I also contacted Elorac, Inc., the manufacturer of Durasal. At the time, a company representative told me they recently stopped making the wart remover and would be replacing it with another salicylic acid solution called Virasal. But I later learned the information given to me was not correct; Durasal is still around.
In their alert last week, FDA told pharmacists that due to the potential for confusion between these two products, they should be vigilant when filling prescriptions for Durezol eye drops. That’s nice to say, but telling pharmacists or anyone else to be vigilant or more careful is a weak error prevention measure. In fact it’s at the bottom of the list of patient safety measures, leaving you as the last line of defense to prevent an error.
It seems to me that the way you prevent errors like this one is to either change one of the product names or get one of the companies to stop manufacturing their drug. FDA did say that they asked Elorac about discontinuing or recalling their drug but the company has not responded. So Durasal is still on the market as of today, as is Durezol. No changes have been made to either drug name either, which seems unconscionable given that ongoing danger exists.
As I mentioned in my earlier blog, one way you really can help with prescription safety is to always make sure your pharmacist knows why you are taking a medication. Knowing this can help her read the correct medication on the prescription, particularly when two or more medications have very similar names.
Finally, you can help by sending an e-mail to Elorac, the Durasal manufacturer. Simply ask them to recall Durasal because of the danger of name confusion with Durezol and the potential for eye injuries. Since they already have their replacement product Virasal lined up, it seems that it would be far less of a problem for them to remove Durasal than to have Alcon, the Durezol manufacturer, go through a costly name change for their product, especially since eye doctors and others already know the name of their product. Besides, the product isn’t even FDA-approved in the first place.
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