Have you ever been in a situation where something comes out of nowhere and you are too surprised to react? A parent recently shared an experience that had all of us in a private Facebook group for parents of children with food allergies up in arms. I asked if I could share it here on their behalf to prepare others for questions that would otherwise catch them off guard.
To set the scene, imagine you are at your school’s “meet the teacher” night and dropping off medication, paperwork, and of course epinephrine auto-injectors:
“[They] promptly took out the [EpiPens] and split the two pack and handed one back to me. I kind of had a mini-meltdown […] I said what are you doing? You’re not supposed to split a two-pack. She told me that was [District] policy. She then checked with the nurse who said she’d been doing this for 17 (?) years and that they don’t ever keep the second one because, according to [District] policy, only a nurse is allowed to administer the second dose and that a nurse will almost never be on campus. I was a little shocked and replied that I was told NEVER to split the two-pack. They told me they could keep the second one, if I insisted. They told me they had been splitting the two-packs all morning and I was the only one who said something. […] This was new to me as last year they took the two-pack, no problem.”
The parent here, let’s call them Pat, is entirely correct. Epinephrine auto-injectors come in packs of two for very specific reasons. In researching for this post, I stumbled upon a 2008 post from “Our Story: The Good, the Bad, and the Food Allergies” by Janeen Zumerling where she discussed being faced with a pharmacy trying to fill one prescription for a 2 pack of EpiPens instead of more because they figured two pens came in one box. So while this is the first time I’ve heard personally about this happening, it could happen at school, at the pharmacy, or elsewhere.
Suggestions as to How to Respond
(The following come with the overall caution to remain respectful, polite, and evidence based in your appeals to the decision maker in question – it may also not be a good idea to have these discussions in front of your child, depending on their age, if they are present when the attempt to split injectors occurs):
1) “This is how my doctor prescribed it.”
Sometimes people will back off if you tell them the instruction comes from someone other than yourself, like an allergist or physician. My daughter’s allergist writes her prescription for a “two pack” – does yours? In the story above, Pat was told that the school nurse had been doing it this way for years and that no one else had complained, so this response may not work.
2) Stock Epinephrine Laws
If your state has a stock epinephrine bill, as Nevada does, you can point to the bill’s language. Nevada specifically references “two doses” of injectable epinephrine. NRS 388.424 (I’m so used to calling it Senate Bill 453, I had to look up the final Nevada Revised Statutes citation, it makes me happy to see it nestled in the law on the legislature’s website!) reads (in part) as follows:
Each public school, including, without limitation, each charter school, shall obtain an order from a physician or osteopathic physician for auto-injectable epinephrine pursuant to NRS 630.374 or 633.707 and acquire at least two doses of the medication to be maintained at the school. If a dose of auto-injectable epinephrine maintained by the public school is used or expires, the public school shall ensure that at least two doses of the medication are available at the school and obtain additional doses to replace the used or expired doses if necessary.
3) Clarify – EpiPen and Auvi-Q versus Twinject
If your injector is the Auvi-Q or EpiPen, that the Twinject is the only injector where the first dose of epinephrine is an autoinjector and the second is a traditional injection that might cause the concern regarding a nurse administering it. (Source) Even so, the doses should be kept together.
4) Look into self-carrying
If your child is responsible, they may be able to carry both doses on their person instead of having to wrangle a school when it comes to attempts to split doses.
5) Turn to your 504 Plan (or IEP)
Depending on the makeup of your school (public schools fall under this, for example, it is dependent largely on the receipt of federal money), you may qualify for a “504 Plan” for your student. (Source, I discussed school accommodations in my overview of the Fox Chapel case FARE amicus brief as well.) This is a shorthand reference to the accommodation to which you are entitled for your student. Don’t have one? Request a meeting. Even if the person trying to split your injectors is a novice on the food allergy front, they should know what a 504 plan is (stay tuned for a post on what to do when you get blank stares after mentioning it, as happened to a friend of mine recently). Does your plan reference both doses? The plan we have for my daughter references a second dose after 10 minutes if emergency services have not yet arrived. Some schools may not permit a 504 plan where an IEP (Individualized Education Plan) is in place to cover other accommodations, so your allergy procedures should be contained in that document instead.
6) Go higher up
You can speak to someone in the school district that may be more informed than the individual you’re dealing with. If the person you’re facing is a school nurse, use data from the National Association of School Nurses. They have a great guide about anaphylaxis here (aptly titled “Saving Lives at School“) and I’ve isolated the page about two doses of epinephrine below (click the image for a larger version).
7) Research Response Times
This may take some google searching on your part but some areas may have response times for emergency services (ie, 9-1-1) that exceed 5-10 minutes. If you’ve ever been in a traffic jam near your child’s school, you probably won’t be surprised when you do find the stats you need. You’ll see that this is even more important when you see my notes on biphasic reactions below.
8) Know Some of the Reasons Why Epinephrine Autoinjectors Come With Two Doses
Not only could the first injector malfunction, there may be user error (or inexperience) at play in addition to the risk of biphasic (subsequent) reactions from the same exposure or the epinephrine wearing off before help can arrive. I’ve broken this final suggestion down with supporting information I was able to find – sometimes just knowing why a protocol is in place will help you if someone down the line challenges you.
Here is some additional information (background research that I did) that could come in handy if someone tries to force split your two pack of injectors:
A second Dose of epinephrine is required For At Least 1 in 10 patients
While the percentages vary, a second dose is required for 10%-35% of patients experiencing an allergic emergency to deal with the symptoms of the reaction. (EpiPen says 20%, Auvi-Q says 10%-20%, and Twinject says 35%) Remember, of course, I am not a physician and none of this is a substitute for medical advice. I just want to arm people with information that they could use if they find themselves in Pat’s shoes. A study spanning 2001-2006 records for two hospitals in Boston found that 12% of children required two doses of epinephrine as opposed to one per Susan Rudders, MD, of Children’s Hospital Boston. (Source: “Kids With Food Allergies May Need 2 EpiPens” – WebMD Health News, March 26, 2010) The article goes on to quote Dr. Rudders as saying, “The problem is, we really don’t have good ways of identifying who will and will not need an extra dose.”
The effects of one dose of epinephrine may wear off after 10-20 minutes
Epinephrine suppresses the progression of a reaction. (Source) It may wear off after 10-20 minutes, however, which may not be enough time for emergency help to have arrived. (Source) Remember, use epinephrine by injecting it into the outer thigh, call 911, also remembering to keep the patient lying down with their feet elevated and be prepared to use that second dose.
User Error And Device Malfunction
Not that anyone wants to consider making a mistake when the situation calls for epinephrine, but in a high stress situation the person using the product may not know how or may make a mistake. I found an interesting article from 2010 that compared four injectors (it was funded by the makers of the Intelliject, later called the Allerject in Canada or Auvi-Q in the United States) entitled: “A comparison of 4 epinephrine autoinjector delivery systems: usability and patient preference” from the Annals of Allergy, Asthma & Immunology (by Stephanie Guerlain, PhDemail, Akilah Hugine, MS, Lu Wang, MS, in Volume 104, Issue 2, Pages 172–177, February 2010 – the manuscript version is here).
The manuscript mentions that when a device malfunctioned, the likelihood of failing to follow instructions was higher. What I was searching for were stats on malfunction but the reference here admits it is a possibility in a test setting at least: “Studies have shown that patients and caregivers do not always correctly administer epinephrine autoinjector devices. […] There may also be a large time lapse (several years) between when a person is trained on an autoinjector and when it must be used during an allergic reaction. Finally, a patient or care provider may be under significant stress while attempting to provide the potentially life-saving dose of epinephrine when it is used.” Id.
As an aside, I was surprised that the most common error for use of an epinephrine injector was not holding it for the correct amount of time. In the study I looked at, versions of what would become the Auvi-Q (INT02 and INT01 in the study) were used as well as the EpiPen and the TwinJect. “The INT02 device resulted in participants committing this [(not holding long enough)] error 11 times compared with 27 (INT01), 40 (EpiPen), and 42 (TwinJect) times.” Training across devices was held to be crucial, with the manuscript indicating that “[t]he fact that less than 50% of participants across all devices could follow the labeled instructions without committing a single error provides confirmation that the need for training on the use of epinephrine autoinjectors is still important.”
I didn’t mean to get sidetracked but I found it interesting. At any rate, someone administering the medicine could not hold it long enough, the device itself could malfunction, the person may not be adequately trained, or the stress of the situation could cause errors as well. With these things in mind, a second device is a very important thing to have.
The first time I heard of biphasic reactions I was fairly shaken. It isn’t enough to worry about accidental exposure to an allergen without now thinking that you could have the reaction, be stabilized, only to have it return like an aftershock even hours later. A biphasic reaction is defined as “a worsening of symptoms requiring new therapy after resolution of anaphylaxis.” (Source) (This Post Updated 12/1/14 to include this post by Dr. Anne Ellis about Biphasic Reactions: “Biphasic Anaphylaxis: What You Should Know“)
I hope some or all of the above is useful! I also hope you don’t run into push back when you work with your school. Pat was able to get the school to retain both EpiPens and I really appreciate the talking point the story provided (thank you!).
As I stated in my post regarding EpiPen and Auvi-Q expiration dates (people are reporting in the comments that they’re receiving their $400 Auvi-Q savings cards in the mail in about 2 weeks after reporting short dated injectors, check out Amazing & Atopic and Food Allergy Pharmacist for even more if you’re following the issue), I have connections at both Mylan and Sanofi (I am the co-founder of the Food Allergy Bloggers Conference and they are both sponsors and my travel, hotel, and some food was covered for my attendance at the Mylan Summit earlier this year) – see my disclosures page as always for more.
The opinions herein are my own, do not constitute legal advice or medical advice, and are provided merely as discussion points. I am an attorney and parent of a child with food allergies living in Southern Nevada.