Epinephrine: Medical & Ethical Necessity or Legal Nightmare?

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As an outdoor program director I’ve had to deal with the complicated ethical and legal issues of epinephrine for many decades. I want to especially thank Reb Gregg and Catherine Hansen-Stamp who presented on this topic a number of years ago at the Wilderness Risk Management Conference (WRMC) and Frances Turner Mock and Seth Hawkins who recently presented on the topic at the WRMC. I have drawn on their presentations in formulating my own opinions about this issue. Let me state at the outset that I am not a lawyer, so everything that I write here is merely my opinion as an outdoor professional and should not be taken as legal advice. Consult legal counsel in your state or province to understand what the laws are and make an informed decision about how your program will address this issue. I hope this article will stimulate both our industry and you and your program to have the kind of intentional discussions that this topic deserves.

Rick Curtis
Founder, OutdoorEd.com


 

Epinephrine Survey ResultEpinephrine Survey Result

Introduction

Epinephrine, it’s one of outdoor education’s ‘unspoken secrets.’ Something you don't like to talk about outside your program, lest you raise red flags about how your program operates. And that applies both to programs that carry epinephrine, perhaps against state law, and programs that don’t carry epinephrine, perhaps against the best interest of their clients. Well, it’s time to bring this subject out into the open and talk about a serious medical, ethical and legal issue that impacts all outdoor programs. We'll explore the legal aspects of epinephrine use and an ethical model that supports using epinephrine. If you want more information about epinephrine and anaphylaxis we urge you to read this article and share it with others in your program.

At the end of this article, you’ll have a chance to weigh in on this issue by participating in a survey on Epinephrine Usage & Legal Issues for Outdoor Programs and join in on the discussion. We recommend you read the article before completing the survey.

We all know that epinephrine is a drug that can save a life in cases of extreme allergic reactions or extreme asthma attacks. In fact, the administration of epinephrine can be so time critical for saving a life that almost every state in the US and many provinces in Canada already have laws allowing epinephrine to be administered in schools in cases of anaphylaxis from food allergies in children. In the US there is also a US federal law (The School Access to Emergency Epinephrine Act) that covers schools. In the UK the 2012 Human Medications Act was expanded to allow anyone to administer epinephrine when the purpose is to save a life.

In the US, while laws have been passed to save children in schools, it is still illegal to provide the same lifesaving drug in a backcountry setting where you are far from hospitals and advanced medical care. And, of course, many of those laws only apply to children, not to adults who have the same risk of dying from anaphylaxis. How does that make any ethical sense?

So in this article I’ll raise questions, not that I have the answers to, but ones that I hope you are willing to wrestle with just as I wrestle with them for my program. Should you be carrying epinephrine? Are you protecting your program if you carry it or are you putting it more at risk? What about your clients, are you protecting them if you carry it and not protecting them if you don’t? I’ll look at various medical, ethical and legal issues about epinephrine and help you explore the issues that impact your program.

My primary focus will be on the administration of epinephrine for severe allergic reactions (anaphylaxis). That’s because most laws specifically address epinephrine for severe allergies not severe asthma. At the end I’ll talk about what we need to do to include asthma in the discussion.

Definitions

  • Layperson – someone without medical training
  • Trained Non-medical Professional (TNMP) – someone who is not a licensed medical professional and who has been trained to administer epinephrine

Medical Necessity?

Definition

Anaphylaxis is a severe whole-body allergic reaction. The condition can quickly progress to a life-threatening illness either from respiratory failure and/or volume shock. The most common causes of anaphylaxis are insect bites and stings, food allergies, and medications.

Is epinephrine a medical necessity? The answer is, simply, yes. In cases of severe anaphylaxis or severe asthma it is the treatment that can prevent death. Whether you in the emergency room in a hospital or are out in the backcountry, epinephrine is what would be administered. In fact, there are cases of people who died in the emergency room because the physician failed to recognize the problem as anaphylaxis in time to provide prompt administration of epinephrine.

The medical protocols are clear. “The Wilderness Medical Society at the 25th Annual Meeting of the Wilderness Medical Society (WMS) in 2008 convened a panel to explore areas of consensus and uncertainty in the field treatment of anaphylaxis. The panel endorsed the administration of epinephrine to treat anaphylaxis in the field under emergency conditions by trained non-medical professionals[1]

Treatment

The emergency treatment for anaphylaxis is the administration of epinephrine 1:1000 IM either 0.30 mg for an adult of 0.15 mg for children. In addition to epinephrine it is essential to administer an anti-histamine (Benadryl, Zertec or others). While the epinephrine acts quickly reduce airway constriction and reduces the vascular shock associated with anaphylaxis, it is short-lived in the body and the histamines which are released by the body in response to the allergen are still present. As long as histamine is being produced, the symptoms will return once the epinephrine has worn off. An antihistamine blocks the effect of the histamine and is the essential second wave of treatment.

Have you ever administered epinephrine on one of your programs? If not, you’re lucky. While it isn’t common, the chances that someone might need epinephrine for a severe anaphylactic reaction or food allergy have increased significantly over the past twenty years. Since 1997 the number of children with food allergies has increased by 50%. There are now 15 million children in the US alone with food allergies. [2] According to a 2013 study by the Asthma and Allergy Foundation of America (AAFA) published in the Journal of Allergy and Clinical Immunology (JACI), “finds that severe life-threatening allergic reactions – anaphylaxis – are common in the U.S.  According to the peer-reviewed study, anaphylaxis very likely occurs in nearly 1-in-50 Americans (1.6%), and the rate is probably higher, close to 1-in-20 (5.1%).” [3]

Let’s look at some true cases of why epinephrine is beneficial in the backcountry.

It was early September and the college outdoor orientation program group was camped along the Appalachian Trail. The group was cooking dinner and Susan, a participant, headed off to go to the bathroom. As she dug her cathole she stirred up a ground nest of hornets and was stung 14 times. She ran back to camp, agitated and started having difficulty breathing, within five minutes she was in respiratory distress. She’d never been stung before. With their first aid training the trip leaders immediately knew that she was having an anaphylactic reaction. However, they didn’t carry epinephrine. So they did the only thing they could do at the time, they ran as fast as they could to the Ranger Station for help. Luckily for Susan her respiratory distress did not get any worse and the Rangers arrived in time to evacuate her to definitive care.

Or take the case of Natalie Giorgio who died in California from a food allergy in July 2013.

Natalie Giorgio was with her family at Sacramento Camp in California when she ate a Rice Krispie treat, not realizing it contained peanuts. The girl immediately spat it out and told her mother but it was too late. Later she began vomiting, had trouble breathing then went into cardiac arrest. She was then taken to hospital where she was pronounced dead[4]

 

National Institute of Allergy and Infectious Disease and Food Allergy and Anaphylaxis Network criteria for anaphylaxis (NIAID/FAAN)[5]

Anaphylaxis is highly likely to be occurring when any ONE of the following happens within minutes to hours after ingestion of the food allergen:

1.  A person has symptoms that involve the skin, nose, mouth or gastrointestinal tract and either:

  • Difficulty breathing, or
  • Reduced blood pressure (e.g., pale, weak pulse, confusion, loss of consciousness)

2.  A person was exposed to a suspected allergen, and two or more of the following occur:

  • Skin symptoms or swollen lips
  • Difficulty breathing
  • Reduced blood pressure
  • Gastrointestinal symptoms (e.g., vomiting, diarrhea, or cramping)

3. A person was exposed to a known allergen, and experiences:

  • Reduced blood pressure, leading to weakness or fainting

Signs of Anaphylaxis

 

 

Cautions in using Epinephrine:

There are some cautions in giving epinephrine. Specifically the elderly; those with cardiovascular disease, hypertension, diabetes, or hyperthyroidism; in psychoneurotic individuals; bronchial asthma and emphysema with degenerative heart disease.[6] However, if weighed against the immediate death of the person from anaphylaxis, a prudent medical professional would administer epinephrine in order to save the person’s life.

Ethical Necessity?

We haven’t ever had a Severe Allergic Reaction so do we need Epinephrine?

Here is a question. Does your program have a lightning protocol? Has your program ever had a student struck by lightning or ground current? The answer to the first question is probably yes. The answer to the second question is probably no. Most outdoor programs have a lightning protocol to follow when a thunderstorm is present. The decision to have such a protocol is based on two things: one is basic risk management theory.

Assessing Risk Level

In our work as risk managers we have to assess levels of risk daily and determine how best to respond (see the Risk Assessment & Safety Management Model for more information). The Level of Risk is defined by the following formula:

Probability of Occurrence X Severity if it Occurs = Risk Level

In the case of lightning strikes the probability is extremely remote, however, the potential severity is death or serious injury. So programs have a lightning protocol to reduce the risk of a serious accident. The second reason for having a lightning protocol is that it is considered an industry standard for outdoor education. If you look at major outdoor programs across North America and around the world, most have a lightning protocol.

Now if we compare fatality levels, there are about 25 lightning deaths a year in the US while there are 2-3 times as many cases of fatal anaphylactic reactions. In fifty percent of those anaphylaxis deaths, the person had no previous history of an allergic reaction. 1 That tells us that we have a greater likelihood of death from anaphylaxis that from lightning and that in many cases we’ll have no prior history to warn us or the allergic reaction.

If the risk of death from anaphylaxis is greater than death from lightning why is anaphylaxis treated differently? We have the same situation of a low probability of occurrence and a severe outcome (a risk of death in minutes). That’s where the ethical issue comes into the equation. There are two main reasons that programs don’t carry epinephrine, one is that in some states it is illegal to administer and the other is cost. Let’s look at both of these from an ethical standard of treatment for managing anaphylaxis.

An Ethical Response to Preventable Sudden Death

If we want to establish an Ethical Response to preventable sudden death, let’s start with CPR. The discovery that the providing Basic Life Support in the first few minutes of a cardiac arrest vastly increased survival time changed the way we perceive pre-hospital care. According to the American Heart Association, “effective bystander CPR provided immediately after sudden cardiac arrest can double or triple a victim’s chance of survival.” That led to CPR becoming a common-place technique where a layperson can provide immediate life-saving care outside of a hospital setting until Advanced Life Support arrives. This person is covered from legal liability under the legal principle of the various Good Samaritan laws.

Automatic Electronic Defibrillators (AEDs) took this a step farther. I remember working in an Intensive Care Unit thirty-five years ago. One of my jobs was to read the EKG monitors and to inform the nurses when a patient exhibited a dangerous cardiac rhythm. In those days the idea of an AED, a machine that would analyze a heart attack rhythm and automatically provide shock if needed was unheard of. Now we take it as common-place and learn how to use AED as part of CPR training. CPR and AEDs provide critical life support in those first few minutes until a 911 call goes out and Advanced Life Support arrives. Giving the legal authority to provide these treatments into the hands of the general public saves lives every day.

The other reason for this shift in ‘legal tolerance’ towards laypersons or TNMP giving epinephrine are changes in children’s health over the past twenty years. There has been the huge increase in food-based allergies in children and also an increase in asthma in children. Both of these conditions mean that children are at risk of sudden death from either anaphylaxis or severe asthma attacks and those situations have prompted lawmakers to act with laws allowing epinephrine in schools. All of this means that society’s view of an appropriate response to Preventable Sudden Death is changing.

While CPR and AEDs are accepted, epinephrine is still not in many states. By providing an ethical criteria for when to use certain treatments, we clear a pathway for legislatures to enact appropriate laws. I propose the following Six Ethical Criteria for when Advanced Medical Treatment should be provided by Trained Non-medical Professionals (TNMP):

Six Ethical Criteria for Using Advanced Medical Treatment by Trained Non-medical Professionals (TNMP)

  1. Immediate application of the Treatment can be life-saving and withholding that Treatment can result in almost immediate death
  2. The illness has specific signs and symptoms that can be readily identified by a TNMP
  3. The Treatment is the Definitive Care for the condition
  4. The Treatment is feasible for a TNMP to provide outside of a hospital setting
  5. The Treatment itself has significantly low contraindications and is by itself unlikely to cause significant harm to the patient
  6. The Treatment can be easily taught to non-medical professionals

Providing CPR and administering an AED meet all six criteria. The administration of epinephrine in anaphylaxis and severe asthma also meets all six criteria and therefore meets the ethical response to preventable sudden death. Does mean that I am advocating that a TNMP should be able to do any kind of treatment when sudden death is a possibility? Absolutely not. It’s not appropriate, for example, for a TNMP to start doing tracheotomies in the field for a person with an obstructed airway. Such a treatment would not meet all of the six criteria outlined above and there is a real chance of harming the patient (cutting arteries, etc.).

Epinephrine costs too much

There is no question that epinephrine autoinjectors are very expensive. Given that the drug itself is very inexpensive I can’t help but think that the Pharmaceutical Companies and making a big profit on autoinjectors. There are less expensive ways to administer epinephrine than autoinjectors. However, these methods can bring additional legal complications.

Methods of Administration

Autoinjectors: These are prefilled devices that automatically inject a single dose of epinephrine. The main brands in the US are the EpiPen and Auvi-Q. Both have needles that automatically retract after injection to prevent blood borne pathogen exposure from a needle stick.

Epinephrine Injectables

Prefilled Syringes: Some organizations get syringes prefilled with the correct dose of epinephrine. The dicey legal issue is who filled the syringes. If it was not done by a licensed pharmacist or a health care provider licensed to dispense medicine, then there may be liability for the organization especially if the dosage was incorrect. There is an added risk of an exposed needle after the injection which can lead to blood borne pathogen exposure for others in the group.

Bottle/Ampule and Syringes: In this scenario the organization carries epinephrine in a bottle or ampule and the instructor draws up the dose on the scene. Like the prefilled syringe, if the person preparing the medication isn’t licensed to prepare a medication then the organization faces increased liability both from the preparation and/or if an incorrect dosage was given.[7] There is the also added risk of an exposed needle after the injection which can lead to blood borne pathogen exposure.

Despite the high costs, from the ethical perspective cost by itself is not a good reason for not carrying a lifesaving item. We pay high prices for all sorts of ‘safety related equipment’ everything from PFDs to climbing helmets. We do this because these things are proven to reduce the possibility of injury and because they are accepted industry practices. In some cases, like PFDs they may be required by law.

Legal Nightmare?

We’ve already begun talking about some of the sticky legal issues with epinephrine when I discussed the different methods of administering the drug.

Let me clarify again that I am not a lawyer, so everything that I write here is merely my opinion as an outdoor professional and should not be taken as legal advice. The laws are different in each state/province and country and you need to consult with a lawyer in your region who knows those laws to best decide how your organization should proceed.

If we look at the various laws in the US you see that in the last few years there are more and more laws allowing Trained Non-medical Professionals (TNMP) to administer epinephrine in specific circumstances. There are links to a summary of the current laws below.

Legal Issues in Administering Epinephrine

In their presentation at the 2014 Wilderness Risk Management Conference, Frances Turner Mock and Seth Hawkins identified the following areas of legal risk for different people within the epinephrine administration chain:

Physicians

  • Unless specifically provided for in state law, Physicians and other licensed practitioners can only write a prescription medication for a specific individual, not to an organization for use by some unknown third party.

Pharmacies

  • Unless specifically provided for in state law, pharmacies can only dispense a prescription to an individual not to an organization.

Outdoor Instructors

  • If the law does not specifically allow a layperson to administer epinephrine, then the layperson  can’t legally administer the drug.

Organizations

  • If it is against the law in your state to administer epinephrine, then a policy that requires your staff to administer epinephrine is unenforceable. You can’t require someone to break the law as part of their employment. The employee has the right to refuse to follow the policy.
  • Negligence per se: This is the legal doctrine where an act is considered negligent because it violates a state law or regulation. If you do administer epinephrine in violation of the law, then it can be considered negligence per se.
  • If your state has a law that allows you to use epinephrine and you travel to another state with different laws, you are bound by the laws of the state that you are in, not your state’s laws.

Laws Permitting Epinephrine Administration

The default laws regarding prescription medications is that only a medical practitioner licensed to prescribe medication can write a prescription. The prescription is written for a specific person and can be used only by that person. Anything else is illegal. Crafting laws that allow TNMP to administer epinephrine come down to 4 key areas.

  • Prescribing – a law needs to permit epinephrine prescription to be written either by an individual and/or organization for administration to a third party.
  • Obtaining – a law needs to allow pharmacies to sell epinephrine to an organization.
  • Stocking – a law needs to allow an organization to keep epinephrine in stocks for use by TNMP
  • Administering – a law needs to provide that a TMP can administer the epinephrine to someone without a specific doctor’s order

Epinephrine Laws

There are a variety of laws that allow for laypersons to administer epinephrine. The most extensive in the US is Alaska so that’s a good one to focus on since it covers everything you’d want in an epinephrine law. The Alaska law covers every aspect of administering epinephrine:

  • Epinephrine can be administered by a TNMP.
  • Epinephrine can be given in cases of severe anaphylaxis or severe asthma.
  • Epinephrine can be either in autoinjector form or drawn up in a syringe.
  • Individuals are allowed to get a prescription and purchase epinephrine to carry for emergency administration to other people.
  • Training is outlined for lay people wishing to administer epinephrine.
  • A person administering epinephrine to another person is provided with immunity from liability.

It’s not surprising that a state like Alaska with some segments of the population living far from Advanced Life Support has a progressive law like this to help save lives.

US States with Epinephrine Law for Food Allergies

from the Food Allergy Network

Summary of Epinephrine Laws

Am I at more legal risk if I give it or if I don’t give it?

That’s ultimately a question for your legal counsel. Either way there are legal liabilities. In the end you have to weigh the risk of exposure for legal action if administering the drug is against the law balanced against the exposure if someone dies on your program because you did not give the drug. Separate from exposure of breaking a law you always have exposure from a civil lawsuit in the event that someone dies or is seriously injured either from failure to give epinephrine or giving it improperly.

What Can You Do Next?

What if you don’t have a law yet or the law is inadequate?

In that case you want to everything you can on the front end to avoid scenarios where anaphylaxis can occur. Here are the top two suggestions:

  • Do Good Medical Screening: Identify anyone (participants and staff) who has an allergy that could lead to anaphylaxis and make sure they bring their own epinephrine. Have them show it to you before the trip and check the expiration date.
  • Do Good Dietary Screening: While you prevent insect stings, you can be aware of food allergies and make sure that your program can accommodate people with food allergies. Knowing about food allergies in advance and having options like peanut-free trips will decrease the potential of a life-threatening exposure.

Get the Law on your Side

It’s time to get the law on your side. Research the laws that already are on the books in your state. Find out what situations a layperson or TNMP can provide epinephrine. Most states have laws on the books for schools and some also have laws that apply to camps. Look to see who are your natural allies--if you are a college outdoor program, talk to your peer colleges. If you are a camp, talk with other camps. Talk with outfitters, outdoor education providers, everyone who has a stake in getting approval and join forces.

Then talk to legislators and get them on your side. Show them the states with laws on the books (like Alaska’s). If school children in the state are already protected in schools (that are minutes away from Advanced Life Support), shouldn’t they also be protected when then are farther away from Advanced Life Support at a camp or on the trail?

Why do you start with children? Well, there are already laws in plenty of states to protect children and if a new law will protect children it’s an easier thing to sel to legislators. Along the way make sure you include provisions for adults in the law.

As an example, here in New Jersey there is a law that allows secondary schools to provide epinephrine to children, however, it only applied to school children. A consortium of New Jersey Colleges approached the state legislature about a law for colleges and universities and the bill was signed into law in 2014.

What’s Next?

For all outdoor education providers we need to work towards national legal standards. Many programs operate in multiple locations and trying to keep track of the differences in laws from state to state or province to province is onerous. If you cross a state line while hiking on the Appalachian Trail you are suddenly under a different set of laws. The best way for us to provide the quality care in the backcountry that we know is absolutely necessary is to have a consistent application of law for a well-understood medical issue. While we are making progress on epinephrine’s use in anaphylaxis, death from a severe asthma attack is often absent from these laws. We need to encourage lawmakers to apply the same Six Ethical Criteria for Using Advanced Medical Treatment by Trained Non-medical Professionals to the treatment of severe asthma attacks.

In their consensus statement about administration of epinephrine by trained NMP, the Wilderness Medical Society said, “in time, legislative change on the federal level should establish uniform protection in all 50 states. It may take parents who have lost a child to anaphylaxis because epinephrine was not available to push through changes in state and federal laws, as happened in the Canadian school system with Sabrina's Law.”

Final Thoughts

I can’t tell you what to do legally. What I do know is that epinephrine saves lives. Ethically, there is no question in my mind that saving a life by giving epinephrine in these situations is the correct thing to do rather than watching someone who could be saved, die. Is it legal? Not in a number of states. Speaking for myself, I would rather face the legal ramifications of being sued for trying to save a life with a drug that physicians recommend lay people be able to give, rather than being sued for a death because I failed to act. My hope is that the overwhelming medical evidence would serve as a valid legal argument for my actions. And if I’m wrong, and I lose the legal case? At least I could sleep at night knowing that I saved a life, or did everything reasonably possible to save a life. I doubt I could if I did nothing, and someone like Natalie Giorgio died as a result.

It’s time for the law to catch up with the medicine.

 

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Resources

References

American Heart Association - http://www.heart.org/HEARTORG/CPRAndECC/WhatisCPR/CPRFactsandStats/CPR-Statistics_UCM_307542_Article.jsp

 

[2] Epinephrine and Outdoor Programming – presentation at the 2014 Wilderness Risk Management Conference, Frances Turner Mock and Seth Hawkins.

[7] Medication Errors in Prehospital Management of Simulated Pediatric Anaphylaxis - http://informahealthcare.com/doi/abs/10.3109/10903127.2013.856501   

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