OK, now that we have that out of the way... :)
I'll have to have a separate post on the rest of the summit, otherwise this will be 2 miles long, so without further ado...here is the low-down on the Auvi-Q™: (Remember, except for items in quotes, or where specified, these are my opinions and assessments and do not reflect the opinions of Sanofi US or its subsidiaries or partners, etc. I am not a medical professional. I'm just a mother, so please consult a physician when making decisions about medication usage.)
- "Developed by patients, for patients®" - Designed by Eric and Evan Edwards, it is the product of at least 15 years of dedicated education, research and innovation by twin brothers who have lived with the risk of anaphylaxis and know this condition first hand. This is not a widget being marketed AT us. This is a solution that was dreamed up and materialized FOR us, by two men who understand our needs, because they share the same needs. They founded a company, Intelliject, then partnered with Sanofi US and here we are, on the precipice of what I'm hoping is a great shift towards higher rates of patient carrying of epinephrine. It always makes me shudder to read the statistics that as many as 2/3 of those who should carry epinephrine do not do so, and we read story after story about a teen who has died from an allergic reaction and the repeating part of the story is that they were not carrying their epinephrine. I am very hopeful that this is the device that will finally change that!
- It's so much smaller than I imagined! - When you see it on their website, it's floating in all this white space, and even though they give the description that it's the size of a credit card, and many of us have taken out credit cards to gauge the size, when we saw it in person, we were still amazed at how compact it was, in our hands! The tapered design makes it very easy to grip, like it's molded to your palm. It's about the thickness of a Blackberry and can easily fit in a shirt pocket, pants pocket, etc.
- Temperature concerns - We asked about the temperature range and since it holds epinephrine, it's subject to the same exact temperature limits (59º-86ºF) that we've always had, but that's not so bad. The epinephrine is protected by the outer cartridge and should reasonably hold up to being held in a garment pocket, though Sanofi US representatives couldn't give us an "official" blessing on that, since no official study was done on body head transfer through any particular type of clothing, etc. However, in my humble, non-medical opinion, the slightly out-of-temperature-range epinephrine that you have with you, works MUCH better than the perfectly maintained epinephrine that you left at home!
- Retractable needle - NO swinging required - When you administer the Auvi-Q™, you remove the safety cover, then the safety cap, and you gently press it into the thigh. The trainer will make a "hiss" sound, simulating the administration of the medicine. It happens in a matter of a second, yet it has you wait for a count of 5, just to be perfectly safe. The needle retracts, immediately, and the patient never sees it. What I loved about it, is that you do not have to swing and/or jab it into the thigh. As I recounted in my post, my daughter told me it wasn't even the needle that hurt, but the actual housing of the needle and the pressure I had to put on her leg, to administer the shot, that hurt. The Auvi-Q™ has a wider base, so the pressure is diffused over a wider surface area. Oh, and the needle is just as thin, from what I was told, so there shouldn't be any pain involved there, from what my daughter described...
- The trainer is GRAY! - There is no confusing this trainer with the real thing, or vice versa! The labeling is dark gray, and the word "TRAINER" is embossed on the top. The audio prompts say that it's a training device more than once. There are labels all around it that reference the fact that it's a trainer. The insert that comes with it tells you it's a trainer, and it practice often, but to remember to always carry your active device for emergencies. At product launch, a prescription will come with two live devices and one training device.
- Color-coded dosage levels with weight ranges right on the label - Many, many a time, I have seen message board questions (and I have asked the question myself) about the weight limits and differences between the 0.15mg dosage and the 0.3mg dosage. Now, it's right on the label! I only have one child, so it's not an issue for me, but if you have more than one, I think an easy way to remember the dosage for younger children, weighing 33-66 pounds is "BABY BLUE", even though not many babies are 33 pounds. ;) Also, remember, these weigh limits are the same as they have always been and are inherent to epinephrine and not the Auvi-Q™, itself. The administration guidelines and real-world usage of epinephrine still remain the same.
- Voice prompts not tied to medicine use - You do NOT have to wait for the voice prompts to administer the device. Before we even asked about it, during the presentation, they told us that if we were already trained and ready, we could just take off the cover and cap and administer the device right away. The voice prompts do not affect the administration of the medication. The trainer insert states that the batteries in the trainer (which I assume are similar to those in the real device) will allow you to practice with the device every day for 2 years. Even if due to some glitch, the batteries did not work, the device will still administer the medication. They are independent of each other. There are also the visual cues (pictures) on the device to show you what to do, should the audio not work, or if the person does not speak English, etc.
--I made a quick video to show how you can just take off the cover and safety cap and bypass the voice prompts to get right down to business. (It's not my best videography, but you get the idea.) ;)
- Language and launch date - Currently, for the U.S. launch, it will only be available in English and they expect it to be available sometime in the first quarter of 2013, so we could see them by March 2013. (When it is launched in Canada, where it will be called the Allerject™, it will be available in English and French, as required by law, but I have no information on a release date for that.)
- Pricing - Though the specific pricing was not available, I would expect it to be comparable to what is currently on the market. It would behoove them to be competitively priced, but I also understand that they have 15+ years of R&D expenditures to recover, plus this product is superior, advanced, etc. Since this is a medical device, the cost to the patient will vary tremendously, based on insurance plan tier, local drug store promotions, etc. They have a program called Sanofi Patient Connection through which those needing financial assistance may be able to receive help in obtaining the medication they need. (Update: If you go to www.auvi-q.com/signup, you can get a coupon for a maximum co-pay of $25 (up to $60 off co-pay), or $60 off the cash price.)
- Imagine the possibilities! - This device is so small and represents a quantum leap in the delivery of injectable epinephrine. This is *not* a "talking EpiPen"...It's NOT even a pen! At first, I thought the best part about it was that it was compact and portable. I was completely underrating the fact that it could talk. Imagine the peace of mind this device can bring to friends, relatives, caregivers, school personnel, etc. I'm hoping this will also help bring peace of mind to parents who are nervous around injectables. For many of us, it takes that first experience to get over our fears, but when you see, hold and hear this device, I'm hoping you will find it as comforting as I did.
- The "cool factor" - Even though this is a life-saving device, which is as serious as it gets, I also think it's just plain cool. I'm hoping tweens and teens will find it equally appealing, as well. I think it's discreet in size, and for those obsessed with having the latest in tech gadgetry, I'm hopeful that this will be the must-have item for their collection. Also, there's really just no excuse left for them to NOT be carrying their epinephrine, anymore. If they can carry a smartphone, iPod, etc., then they can find a space for their Auvi-Q™s!
|The trainer sitting on top of an HTC EVO|
|I am 5'3" (OK, 5 2 1/2") and I have small hands - |
my index finger and thumb wrap all the way around it!
Minor Critiques: (Just to prove that I'm not completely clouded by my overwhelming love for this product!) ;)
- The audio script on the trainer is not identical to what the actual device tells you. Now, of course, you want the device to start off by telling you it is a training device, but it does not mention the part about seeking emergency medical attention. I know you don't want it to tell people to actually seek medical attention, but it could say, "If this were a true anaphylactic emergency, you would seek emergency medical attention", like they do on those "emergency alert system" messages. It just mentions, at the end, that the trainer can be reused for training purposes. I want the people being trained to have that part ingrained in their brains. *Use this device - seek emergency medical care*
- It might be a little "loss prone" for younger ones, like other smaller electronic devices. It might also fall out of pockets, if not properly secured. It was tested to withstand 9-12" of rainfall for 20 minutes, which is completely reasonable, but if it is dropped in a river or toilet, it should be replaced for sanitary reasons. The "dropping in the toilet" is a real concern, if people are carrying it in pockets. I don't think that's anything Sanofi can really solve, but it will be a concern for patients to manage, as they do with all of their small electronics.
- Speaking of electronics, one of the first things my husband asked me about was the recycling of the electronics when we get a new device. He thought the inner medicine would be replaced each year, somehow, but I told him an entire new set of devices would be dispensed, and I think he was a bit concerned about the amount of waste involved. That might be something for Sanofi to look into, as well, if they haven't already. Considering that these devices contain batteries, they must be handled properly when they expire. (Sanofi US's corporate HQ in New Jersey is LEED certified, so I'm sure they'd be open to the prospect of eco-friendly recycling of expired devices.)
- I have a muscle-weakness condition and sometimes have localized minor weakness in my hands. I found the red safety cap a bit difficult to remove, at times. (I have already played with it, oh, about a gazillion times.) It was doable, but I had to figure out just the right angle to give myself enough leverage. I thought of those who might have arthritis and similar conditions. I know we want the device to be somewhat childproof, for the littlest ones, but to me, the safety cap, is just a "safety" precaution, to make sure that we are aware of what we're doing and not something that we want to have as a physical barrier to use. Even my husband remarked that the red safety cap was more difficult to pull off than he imagined and he is a very strong man. He took it off easily upon a second try, but it might be something for Sanofi to consider loosening.
None of those are a "deal breakers" for me, though, and I still have high hopes for the Auvi-Q™. I foresee it saving many lives.
I eagerly await the release of the Auvi-Q™, as I'm sure many of you do, as well. If you have any questions that I did not address here, please feel free to ask. I tried to remember everything, but we covered quite a bit! :) ---> The Auvi-Q has arrived! Check out my post showing what's in the box, now that I actually have the real thing!
P.S. Check out the awesome Grateful Foodie's post about the Auvi-Q™, where she is compiling our posts from the summit, so you can see what everyone else's take on the Auvi-Q™, as well. Thank you, Caroline, for posting the links! :)
P.P.S. Some have mentioned that it's the size of a deck of cards, but it's actually smaller than that. Here is a standard deck of cards I had in the house, that I used for comparison.