by Michael R. Cohen, R.Ph., M.S.
Last week the French pharmaceutical company Sanofi announced FDA approval of their new product, Auvi-Q, a new concept in drug auto-injectors for patients with a history of a severe reaction after a bee sting, or exposure to certain foods like peanuts or shellfish. According to Sanofi, as many as 6 million Americans are at risk for a life- threatening allergic reactions.
Auvi-Q contains the hormone epinephrine (adrenalin), the standard treatment for patients with severe allergic reactions. It’s the same drug that’s in an EpiPen, another auto-injector for use during an allergic attack But Auvi-Q may hold advantages over the EpiPen from a safety standpoint because of its unique voice-guidance system and overall design that makes using it more intuitive.
One of the main issues with EpiPen has been that those who need to use an EpiPen do not often find themselves in situations where the pen is actually needed. So even though they may have initially been trained in proper use of the pen, they aren’t really as prepared as they need to be during the actual emergency.
We still occasionally hear about patients who’ve injected a thumb or finger. You’re supposed to firmly hold the needle end of the EpiPen against the thigh (even against clothing) for 10 seconds to release the injection. But inadvertently, the device is sometimes held with the release button against the thigh and the unexposed needle end against the thumb. That leads to injection of the thumb, causing pain and decreased blood flow due to constriction of tiny blood vessels. It also wastes the shot since little, if any, gets absorbed into the circulation. There also may not be a back-up pen available for the allergy emergency.
Google “EpiPen thumb injection” and you will find scores of cases, including some by health professionals. Several years ago the manufacturer of EpiPen, Dey Laboratories, changed the pen label to highlight how the pen should be held in the proper direction. However, this hasn’t helped avoid the problem 100 percent.
Another more recent problem with the EpiPen is one I wrote about just a few weeks ago. This past year the company began to include an EpiPen training pen in product packaging. This practice pen, which has no active drug, has sometimes been confused with an actual live EpiPen. We’ve had complaints about this from hospitals although no actual accidents have been reported. There is however at least one report where a mother accidentally used the real pen on herself when she meant to use the trainer. The fear of course is that the trainer will accidentally be carried for use in a real emergency, leaving a patient at least temporarily untreated.
The new Auvi-Q seems easier to use correctly. It’s about the size of a credit card and thin enough to be carried in a pocket. More importantly, instructions are voice guided, making mistakes much less likely during a life-threatening emergency. After the device is pulled from its case it “talks” users through each step of the injection process. You can view a demo here. Otherwise, the steps needed are on the product label. I haven’t had the opportunity to fully examine Auvi-Q but it’s also said to have a retractable needle system that prevents accidental needle sticks. I like the “talk through” concept very much and hope to see it used in other situations where medication delivery is fraught with possible danger, including in hospital situations.
One possible downside with Auvi-Q is differentiation between adult and pediatric doses. With EpiPen there is an EpiPen and an EpiPen Junior for pediatric patients. With Auvi both are just Auvi-Q. They are colored differently but the text on the label doesn’t clearly state which one is for pediatric patients and which is for adults. Also, an oval that provides the weight range that correlates which one is for children, the font size is tiny and the text blends into the background color making it hard to read. In families where both an adult and pediatric patient resides, this could become a problem.
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