Mari Dark of Naropa University recently posted a question to the SECUSS-L listserv asking if members included epinephrine in their medical supply kits for faculty led trips. She received 13 responses: 9 argued against it and 4 were for it.
She reported that the majority of respondents’ programs did not provide epinephrine. Presumably that also means that their programs do not authorize carrying epinephrine. This distinction is important as illustrated by the University of New Hampshire faculty leader whose trip to Nicaragua was cancelled in 2013 and whose appointment was not renewed by the University after it came to light via her submission of an invoice that she carrying unauthorized epinephrine on program.
The respondents’ arguments against carrying epinephrine centered around concerns for liability and a consensus that students should be responsible for their own medications. The assumption underlying the first argument is that you are more likely to be sued as a result of carrying epinephrine than you are if you don’t. The second argument assumes that allergy/anaphylaxis is a pre-existing condition that you either have or you don’t.
So…why is this becoming a hot topic in study abroad? And are programs more likely to be sued as a result of carrying epinephrine as opposed to not carrying it? Are allergies a pre-existing condition that you either have or you don’t? And, should study abroad programs be carrying epinephrine overseas?
First, a quick primer: An allergic reaction is an abnormal response by the immune system to a foreign protein. Anaphylaxis is a life threatening systemic allergic reaction. When some individuals are exposed to common allergens such as nuts, pollen, bee stings, etc., their immune system marks the foreign protein as a threat. In subsequent exposures to the protein, their immune systems mobilize to fight the perceived threat. There is an accompanying release of histamine from white blood cells that causes systemic vasodilation (the widening of blood vessels) which can cause a life-threatening drop in blood pressure and lower airway constriction. The treatment for anaphylaxis is the administration of injectable epinephrine. Epinephrine (synthetic adrenaline) causes vasoconstriction. There are some additional adjunct treatments including antihistamines (Benedryl™ or diphenhydramine) and steroids (prednisone). Some physicians are currently advocating against the use of antihistamines because they may hide some of the less serious symptoms and be a distraction from the administration of the epinephrine, which is the only treatment that will reverse the vasodilation. Prednisone will stabilize the immune system but does not quickly resolve vasodilation. The administration of epinephrine via injection is a relatively simple procedure especially if employing an auto-injector. Epinephrine is an intramuscular injection. Unlike an intravenous injection, it does not require significant training, skill or experience to administer competently.
Why it has recently become a hot topic was well spelled out at the September 2014 Wilderness Risk Managers Conference (WRMC) where Frances Mock, a Duke law professor, and Seth Hawkins, a physician, presented the latest thinking regarding epinephrine use on adventure education programs. All the points they made are relevant to study abroad programs as well, although there are some additional considerations when going abroad.
Some of the points they made and trends they identified:
- According to the U.S. Centers for Disease Control food allergies have increased 50% between 1997 and 2011.
- There are more than 50 fatal sting reactions in the U.S. annually. Half of those had NO history of previous sting reaction.
- The Centers for Disease Control has taken a more aggressive stance: epinephrine should be administered “at the first sign of an allergic reaction, especially if the child’s breathing changes”
- The School Access to Emergency Epinephrine Law, a federal law that went into effect in November 2013 rewards states for requiring schools to train staff to administer epi and have epi available for use
- Is administering epinephrine considered practicing medicine? The following organizations regard it as first aid, i.e., a procedure appropriate for lay persons:
- American Red Cross
- American Medical Association
- American Academy of Allergy, Asthma and Immunology
- American Academy of Pediatrics
- CDC advocates use by lay people
- Some states explicitly say that it is not practicing medicine and that it is first aid
Mock and Hawkins were not advocating per se for all programs to carry epinephrine however. There are some complexities and their goal was to assist their audience with making good decisions for their organizations.
So, are you more likely to be sued for carrying epinephrine than for not carrying epinephrine? Putting aside moral and ethical issues (are you willing to take a chance that someone will die of anaphylaxis because of concerns for liability?), what is the pragmatic likelihood of being sued with either course of action. When we think of lawsuits, we are talking about civil law and a likely charge of negligence. To establish negligence, you need to demonstrate the existence of 4 conditions:
- A duty to act
- A breach of the duty
- Causation, i.e., the breach resulted in the harm
Any hypothetical legal argument would be about the scope of the duty or standard of care, which would need to be defined in order to determine if there was a breach of the duty and therefore whether or not there could be causation. The surest way to avoid a lawsuit is to avoid harm. There is of course a concern that improper use of epi could cause harm and liability exposure. However, if you were to administer epi to someone who actually did not need it, the likelihood of them sustaining anything other than feeling unpleasantly jittery is quite low. The increasing appreciation that epinephrine is not a particularly dangerous drug is part of why there has been a shift toward regarding it as first aid.
Despite over 30 years of adventure education programs carrying epinephrine (and some study abroad programs) – and numerous documented cases of administered epinephrine (including some improperly administered epi in the earlier days), I am not aware of any lawsuit concerning improper use of epinephrine in a program.
In fact the only lawsuit involving epinephrine is Giorgi v. City of Sacramento filed in 2014. A 13 y/o girl whose only history was a mild reaction to peanut butter when she was 3 y/o, went into anaphylaxis after eating a rice krispies treat made with peanut butter. Her school’s epinephrine was locked up and the key was not readily accessible resulting in a delay in the administration of epinephrine. Part of the suit is about negligence for failing to have epinephrine readily available.
There are some additional caveats. Reb Gregg, another lawyer who has been very involved in the WRMC, has stated for years that it is illegal to prescribe a drug to a program and not an individual. Dr. Hawkins pointed out however, that it is not difficult to find a physician who will write such a prescription or for a pharmacy to fill such a prescription. The legal issues are mostly state by state and when you are talking about going overseas there is some added complexity. In many or most other countries, you can buy epinephrine over the counter.
Is anaphylaxis simply a pre-existing condition that can therefore be managed by students being responsible for their own medications, or in the case of minors, having teachers manage the students’ medications? As per the Mock/Hawkins data 50% of anaphylaxis deaths secondary to hymenoptra (bees, hornets, fire ants, yellow jackets, wasps, etc.) stings were individuals who had no prior history of allergy or anaphylaxis to stings. The data shows that food history is more pertinent but our immune systems evolve and while you would be very unlikely to see someone having their first asthma attack, it would be significantly more likely that you’d see someone having their first allergy/anaphylaxis event for which they would not be carrying any epinephrine.
So, should your program carry epinephrine? From a safety perspective, the answer is yes, although I have not heard of any anaphylaxis fatalities in study abroad. From a liability perspective, it seems unlikely right now that you’d be sued for carrying it or not carrying it. But stay tuned. If it evolves into being the standard of care or the de facto standard of care because so many programs are carrying it, the legal landscape may shift.
For now here are the pertinent conclusions from Francis Mock and Seth Hawkins:
- Learn the law in the state where you operate
- Confer with a knowledgeable attorney
- Confer with your medical advisor
- Confer with your Board
- Decide what your policy will be
- Advise staff of your policies and the implications
- Provide notice to participants about your policies and consider getting consent for treatment in writing in advance
- Try to have a doctor available for field staff to consult before administering or as soon as possible after the administration (if you decide to carry)