Last year when I learned about the pending approval from the FDA for an epinephrine nasal spray and also, the trials for epinephrine sublingual, I started thinking about how many of the states have in their statute (law) to have epinephrine available via auto-injectors in schools. In addition, having read the American School Health Association’s Journal of School Health article, A National Review of State Laws for Stock Epinephrine in Schools (2022). The CDC has a link to the full text version, that will download once you click on the link - https://stacks.cdc.gov/view/cdc/114978/cdc_114978_DS1.pdf. I felt there could be something done about this.
Knowing that the nasal spray was not initially approved then reading that the FDA was ready to approve before the end of 2024, I wondered what advocacy effort I could implement to possibly change the statute in my state, New Jersey to allow more than auto-injectors as an option for schools to stock. Yes, if a parent chose to get a prescription for the nasal spray for their own child, we would have to honor it, but what about all the states that specify epinephrine via “autoinjectors” or “prefilled syringe” for their stock doses?
My blog post is, by no means, is an endorsement of the product, but as with many other medications that we know have gone through the clinical trials and FDA-approval process, might be more effective and efficient way to give epinephrine in the community and even in schools. Take for example, naloxone. There was a time when it was only available via injection and only given in hospitals. When I was in the hospital, I gave many doses IV, IM, and Sub-Q. It later moved to be given by paramedics in the field. And now, with the naloxone nasal spray available to emergency medical service providers, school nurses and delegates/designees, who can give it in schools along with the public. We are saving lives, and this is another non-invasive option to do so!
In Spring 2024, I learned about the New Jersey Law Revision Commission (NJLRC), who is “responsible for conducting a continuous examination of the New Jersey statutes and the judicial decisions construing the statutes”. I kept this information in my back pocket and once I knew the epinephrine nasal spray was soon to be FDA-approved, I wrote an email to NJLRC providing information about the current statute as well as pending FDA-approval for epinephrine via nasal spray and also the epinephrine sublingual clinical trials information. By the way, the pediatric trials are in process now for the sublingual.
I received an email back from NJLRC in October 2024 informing me that they are going to perform additional research and take on the project. I was actually very surprised that they accepted my recommendation as an ordinary citizen. Although, I had read on their website, “The Commission also considers recommendations from the American Law Institute, the Uniform Law Commission…and other learned bodies as well as members of the legal community and public”. We have power in places as citizens that we might never think about.
Fast forward to November 2024, I was informed that my statute recommendation would be brought up to the full commission for possible next steps if there was not any objection. Well, I was invited to speak up about my recommendation at the virtual meeting of November 21, 2024. My initial inquiry along with the in depth law research was presented by Mr. Ryan. NJLRC Legislative Fellow and I was given the opportunity to speak. I, thanked the Commission and Mr. Ryan, along with reinforcing the information I had provided back in August. The entire commission overwhelmingly praised me for bringing this to their attention and voiced how innovations in medicine as this will prompt them to start to look more closely at other medications that possibly now have additional routes of administration.
Well, here is the current status of the NJLRC “Epinephrine Project”, the November 21, 2024 Report is available for the public to read and comment on through January 20, 2025. You can read the report at https://www.njlrc.org/projects/2024/10/7/title-18a-updating-terms-related-to-epinephrine-administration-and-nurses?rq=title%2018a. (Scroll down to see the reports). Based on public comments, NJLRC will move the recommendation on to the NJ legislature.
This is really exciting!
Just so you are aware, I submitted to the Commission to insert “single dose” or “unit dose” epinephrine. I felt this important to avoid school districts from considering multi-dose vials of injectable epinephrine. If the statute did not specify, this could potentially happen. As nurses, it would be one thing for us to draw up doses as many of us have done in the hospital, but we want to have the safest administration as possible for our students to receive and any potential delegates/designees to give it. "Single dose" or "unit dose" make the most sense to include in the statute.
So, what is the point to my writing this blog?
- First, if your state allows stock epinephrine in schools, check to see if it only specifies “auto-injectors” or “prefilled syringes”.
- Second, find out if your state has a commission or other method to potentially make a change to the statute.
- Third, write your email! You never know as I did if there is the possibility that my one email from back in August could actually change the “law”!
You can read other information about the federal epinephrine laws by clicking here.
I will keep you posted in the new year on the decision of the Commission and Legislators!