Is Device Design To Blame for Incorrect Epi Adminstration?

 

This past February I was honored to be a speaker at a training session for support group leaders in London.   I learned  a great deal about the commonalities as well as the differences in the ways we approach food allergy management.  While in the UK, I met some amazing “mums” as well as wonderful professionals working in the field of food allergy.  One such professional was Dr. Robert Boyle, a well-known and highly respected pediatric allergist.  Of course, I took the opportunity to pick his brain about some of the concerns we see here in the Untied States.  One such discussion was the effective use of epinephrine auto-injectors by patients.  He let me in on some exciting research he was a part of regarding this very subject.   He shared the results with me but I was unable to share them with you until his paper was published.  Well, the paper has been published and I think the results could impact the choice of auto-injectors prescribed by doctors as well as the future design of epinephrine auto-injectors.

THE STUDY

In this study, patients were trained to use a specific device (Epipen or Anapen).  All patients were able to successfully use the device after initial training.

THEN

They tested the patients’ ability to use the device under simulated anaphylaxis at 6 weeks and at one-year.

NEXT

They switched the devices and did NOT give training with the new device.  (This is a real life scenario that we see here in the USA when insurance companies fail to cover a specific device.)

The purpose of the study was to find if device design (rather than just training) impacted the patients ability to correctly use the auto-injectors.

THE RESULTS

“we have shown… that successful adrenaline administration rates using Anapen and EpiPen are low during simulated anaphylaxis, and EpiPen use under stressful conditions carries a significant risk of digital injection.”
Success rates at the 6-week and one-year intervals were similar, hovering just below 45% for both devices used (Anapen and Epipen).  Meaning that less than half of the participants were able to correctly use the devices at both the 6 week and one year mark, even given successful initial training.
The low success rate is consistent with another study done in the United States that indicated that patients need more training.  However, in this study, the authors conclude that training may not be the only factor but rather device design may be greatly impacting the patients’ ability to correctly use the auto-injectors.
Here is the most significant piece of information for me:
“Over 90% of participants were able to successfully administer adrenaline using Auvi-Q without receiving device-specific training…”
IMG_2214
The success rate for Auvi-Q was an astounding 90%  WITHOUT training!   Success rates for other devices without device-specific training were only  49%.   Hopefully, it goes without saying, that training is very important, but this study has me pondering the role of device design as well.

Of course, this is but one study and I would love to see additional studies.  However, I believe this information is important to share and has an impact on many of the discussions we are having here in the United States regarding use of stock epinephrine in restaurants, schools and other locations.  Could Auvi-Q be a better option in these circumstances?

 

 

The authors believe this is worth discussing.

“the high rate of successful adrenaline administration which we found when participants used the audio-prompt device Auvi-Q, in a stressful anaphylaxis scenario and without prior device-specific training, suggests that Auvi-Q is an important advance in AAI device design and may even be suitable for bystander use in public areas such as schools”

 

Also of interest, were the ways in which people incorrectly used the epinephrine auto-injectors.  The authors hope this information will help aid in device design.

The most common reasons for failing to use the auto-injector correctly were:

  • Failure to remove safety cap
  • Using wrong end of device
  • Not holding device in place long enough

I encourage you to read this study for yourself.

Does this information change the way you manage food allergies?  Please comment below.

 

 

A special thank you to Dr. Robert Boyle for sharing this important study.

References:
Patients’ ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial.
Umasunthar T, Procktor A, Hodes M, Smith JG, Gore C, Cox HE, Marrs T, Hanna H, Phillips K , Pinto C, Turner PJ, Warner JO, Boyle RJ.
Allergy 2015; DOI: 10.1111/all.12628.
Misuse of medical devices: a persistent problem in self-management of asthma and allergic disease
Bonds, Rana S. et al.
Annals of Allergy, Asthma & Immunology , Volume 114 , Issue 1 , 74 – 76.e2

Related Posts:

Do You Know Your Epi?

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10 Responses to Is Device Design To Blame for Incorrect Epi Adminstration?

  1. Nutrimom says:

    Although I see the benefits of having and using an Auvi-Q and the ease of it, I am confident in assuming that similar studies in addition to others are probably being done by Mylan, the makers of EpiPen (as any company is constantly striving to improve upon anything that they can make better for their consumers). I applaud the research that was done for this as ALL research is helpful. I have the best hopes that ALL epinephrine injectors will be easier and more effective in the future 🙂

    • gmleeconsulting@gmail.com says:

      I’d like to see more studies regarding this issue as well. My hope (as well as the authors, I believe) is that this data will be used to improve epi design in the future. I think it is important for consumers to have options.

  2. What a very important post. I had a personal feeling this would be the result after hearing about the errors made by friends and those before my eyes.

    Excellent post

    • gmleeconsulting@gmail.com says:

      Thanks Caroline! I know this is an issue near and dear to your heart as well as mine. We need to make sure patients can administer epi correctly when needed as it is life-saving!

  3. Tania says:

    Thank you! I will be sharing this research with my insurance carrier who will not pay for the AuviQ only Epipen. My 11 year old feels more confident and safe with the AuviQ (insurance covered it previous years) but I can’t pay the $530 it costs without coverage

    • gmleeconsulting@gmail.com says:

      Thanks for commenting Tania! I’ve heard many stories of insurance companies not covering specific brands. Please let us know if this information helps with your appeal process with your insurance company.

  4. Laura says:

    I agree that Auvi Q is great, but insurance won’t cover it for us either. Instead, we regularly (once a month or so) review how to use an epi pen by practicing with the trainer that comes with them. I even have my kids practice on each other. I also stress to all babysitters the importance of taking 30 seconds to read the directions printed on the epi pen – that it is better to take the extra time to do it right, than to mess up and waste more time. Given what we have to work with, we have to make do and hope God makes up the difference until better solutions are available.

    • gmleeconsulting@gmail.com says:

      Thanks for providing these great tips, Laura! I think you are being very proactive! I do like the Auvi-Q. However, I will be eternally grateful to the makers of Epipen as that device saved my daughter’s life. I used it twice in response to my daughter’s anaphylaxis and was able to use it effectively both times. I know that many people use other devices such as Epipen each day and are able to do so without a problem. My hope is that better devices will be developed by multiple companies as a result of studies like this one.
      Practicing until it is part of your muscle memory is really important. I also found it helpful to inject an expired epi into a grapefruit or orange as practice. The Epipen has a strong “kick-back” that I think it helpful to feel before actually needing to use it in an emergency situation.
      Thanks again, Laura! If you have any other great tips, please share!

  5. […] Eye Opener: Gina Mennett Lee writes a stellar piece, “Is Device Design to Blame for Incorrect EPI Administration”.  This post is about a study about how epinephrine auto-injector design can possibly impact ease […]

  6. What a timely article. I was shocked to hear today that my insurance company would not pay for my daughters Auvi-Q and it would cost over $500 for her epinephrine device. From other posts, I can see we are not alone. Not only is the Auvi-Q much smaller and easier to fit in a small purse but my daughter was also very disappointed because she is afraid her friends will not be able to help her in an emergency. With the Auvi-Q automated message, it gave her the extra confidence she needed when she is out with friends. I will appeal this with my insurance carrier but I also would like to see more studies on this in the future.

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