Is Device Design To Blame for Incorrect Epi Adminstration?

Tuesday, April 21st, 2015 | Permalink

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…”

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

Do You Know Your Epi?

Tags: allergy, anaphylaxis, Auvi-Q, Epipen, food allergy, management, patient, research, Robert Boyle, study, Success, treatment, use
Posted in Blog, In the News | 10 Comments »

LEAP Study is “Belle of the Ball” at AAAAI Conference

Friday, February 27th, 2015 | Permalink

By Gina Mennett Lee, M.Ed.

FoodAllergyConsulting.com

“What are you doing?” My husband asked incredulously. My eyes had been glued to my phone intermittently for hours over the weekend.
“Following the AAAAI Conference.”

“What is that?”

“The American Academy of Asthma Allergy and Immunology Annual Conference. I follow it every year to stay up to speed in the latest research. Docs from the conference are tweeting the most recent research and findings.”

As I snuggled into my home, fire blazing in our fireplace, snow falling outside for the umpteenth time this winter, some of the allergy field’s greatest medical minds were gathered to share information, debate current thoughts, and hob-knob.

Twitter is the closest I can be to a fly on the wall at the conference. It allows me access to the thoughts and notes of some of these doctors (some that I have pleasure of knowing) as they are listening to the speakers share their research and findings. Even better, it gives me a chance to ask questions.

I read, “favorite” and retweet furiously so I can refer back later and track down the research to read. Of course, I am partial to information related food allergies and anything relating to the school setting. I was also interested to see lots of discussion on more effective ways to treat asthma patients. I loved reading the tweets about the debate over whether or not OIT (Oral Immunotherapy) is ready for “primetime”. (Seems like the consensus was “not quite yet”.)

But, by far, the belle of the ball this year was the LEAP study.

The Learning Early About Peanut Study debuted as this year’s conference and the food allergy world was literally abuzz. Unfortunately, as this landmark study was released, so were a slew of misrepresentations on the actual implications of the study. Many people wrongly were proclaiming a cure and recommending people expose children with peanut allergies to peanuts.

Unfortunately, this study does NOT apply to the 15 million patients in the USA that already have food allergy.

It is, however, very promising as it indicates a potential to PREVENT peanut allergy in high risk infants. Further studies are being done to see if it applies to other allergens and what the long-term outcomes are for the patients in the study.

Below is a short video describing the thought behind the creation of this study.

For more information on the LEAP study, I invite you to read it as well as this excellent synopsis of it by Dr. David Stukus on the AsthmaAllergiesChildren.com website.

To see more of what I found interesting, you can read my twitter feed. Below are just a few examples.

Disclaimer: Tweets are but a snippet of the information. It is very important to find and read the research that interests you rather than relying on a tweet (or even a news article) to fully convey the information.

I am very thankful to all the doctors and other professionals that took the time to tweet at the AAAAI Conference as well as the dedicated research teams and patients involved in these studies. I hope all this excitement inspires you read some of the research and to follow along with me next year.

Tags: #AAAAI15, #LEAP, AAAAI, asthma, Dr. Stukus, food allergy, LEAP study, peanut, research
Posted in Blog, In the News | No Comments »

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Is Device Design To Blame for Incorrect Epi Adminstration?

LEAP Study is “Belle of the Ball” at AAAAI Conference

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