Durezol is a steroid eye drop prescribed to reduce swelling and pain after eye surgery. Unbelievably, there’s a wart remover with a very similar name called Durasal. The wart remover is a strong salicylic acid (26%) solution. Both products come in small applicator bottles. You can guess what can happen, especially since patients who undergo eye surgery often have difficulty reading medication labels.
One such event led to a $1 million lawsuit against a pharmacy where a mix-up occurred. The pharmacist misread the doctor’s prescription for Durezol eye drops and gave a man the wart remover instead. He put the strong acid in his eyes and suffered “grievous personal injury.” Mix-ups can happen the other way around, too—someone with warts can accidentally get the eye drops, which might worsen the warts since the eye drops are a steroid.
Several pharmacists and nurses have previously reported concern about the risk of mix-ups. One nurse told us she wrote down the wrong medication when transcribing a doctor’s order, but the mix-up was caught before the hospitalized patient received the wrong medication. A medical transcriptionist also reported the risk of mix-ups between these two medications after recognizing the potential for problems when checking the spelling of Durezol. The potential for serious errors is so high that we published a warning about Durezol-Durasal mix-ups in our newsletters and on our websites in January 2010, before we learned about any actual errors.
We had notified the Food and Drug Administration (FDA) and the maker of Durasal (Elorac) about the hazard. I contacted the company again this week, and a representative told me they stopped making Durasal and will replace it with another salicylic acid solution called Virasal. The picture of Durasal was still on the company’s website, so I asked them to remove it, which they did.
End of problem, right? Not by a long shot! You can still find Durasal listed on the Internet, including on government websites and in various drug indexes, including computer prescribing databases. As far as I am aware, the company did not send doctors a letter to notify them that the product is no longer being manufactured. Durasal also has not been recalled and removed from pharmacy stock! After visiting my local pharmacy, I also learned that pharmacies can also still order Durasal from their usual drug wholesaler. So doctors can still prescribe it, pharmacies can still order it, and patients can still get it.
So how can that be? Well, for one thing, even though Durasal requires a prescription, the FDA has never formally approved the drug because it was around before 1938 when the Federal Food, Drug, and Cosmetic Act was passed, giving FDA the authority to regulate prescription medications. But Congress “grandfathered” thousands of pre-1938 drugs, many of which remain on the market today despite never being approved by FDA. It’s only been recently (2006) that FDA initiated a plan to require manufacturers of grandfathered drugs to submit a new drug application (NDA) for approval. This is good news, especially since FDA’s focus has been medicines associated with serious medication errors. FDA is using the opportunity to have manufacturers update labels on their products, including warnings. The process has forced some dangerous drugs off the market when the manufacturer could not prove their product was safe and effective, a requirement in current law. But many pre-1938 drugs, including salicylic acid, have yet to go through this process. FDA has not as yet addressed the risk of mix-ups with other medications that have similar names or any other safety problems. You can check to see if a drug is approved by FDA here. If the drug is not listed, it isn’t FDA-approved.
Allowing any problematic product to remain on the market, FDA-approved or not, is a frustration we deal with at the Institute for Safe Medication Practices. A product might be relabeled or redesigned to eliminate medication errors and manufacturers may even send a letter to doctors and pharmacists when a new serious issue comes to light. Still, products out there before the safety enhancement remain on the market where errors can continue to happen until supplies are exhausted. Unlike other industries, drug companies are not required to do much more than alert doctors about the change or even recall their no-longer-manufactured product — even though a patient might be blinded, or worse!
So when it comes to medications, it’s still you, the health care consumer, who’s the last line of defense to prevent an error. To be safe, please keep yourself informed about your medications. Read labels very carefully, and if you have problems with your sight, ask someone else to read the labels for you. Do NOT store any product not meant for the eye anywhere near eye drops or ointment. Finally, make sure your pharmacist knows why you are taking a medication. Knowing this can help your pharmacist read the correct medication on a prescription, particularly when two or more medications have very similar names.
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