Patient Care

Bystander Epinephrine in Community Anaphylaxis

Issue 4 and Volume 43.

Bystanders can be critical in battling community anaphylaxis

In spring 2017, a 4-year-old boy with a history of peanut anaphylaxis was attending a large barbeque in Vermont when his mother heard someone calling for help. A 65-year-old woman had been given a potluck dessert and inadvertently consumed peanut. The stranger’s symptoms included severe dyspnea and wheezing. She had a known peanut allergy but had forgotten her own epinephrine auto-injector devices.

EMS was activated and a BLS provider arrived by private vehicle in five minutes; however, the provider didn’t have epinephrine. Oxygen was administered by non-rebreather mask but symptoms worsened.

With no epinephrine available, the child’s mother used her son’s Epipen Jr (0.15 mg epinephrine auto-injector) to administer two injections in quick succession.

Rapid improvement was noted and the woman was then able to make eye contact and thank her rescuers for providing epinephrine and rendering emergency first aid. Her symptoms recurred in five minutes, and an additional two doses of Epipen Jr were given before an ambulance arrived 30 minutes later and transport was initiated.

Epinephrine is critically important to people at risk for anaphylaxis; however, barriers to its availability continue to exist.

Discussion

This case represents the value of Good Samaritan willingness to share designated epinephrine auto-injectors. Early access to epinephrine saves lives, and there’s no absolute contraindication to epinephrine in the treatment of anaphylaxis.1 Moreover, rates of anaphylaxis have increased and most cases occur in communities rather than healthcare settings.

Epinephrine is critically important to people at risk for anaphylaxis; however, barriers to its availability continue to exist.

Epinephrine auto-injector devices are only available by prescription and, in accordance with the amended Federal Food, Drug and Cosmetic (FD&C) Act, such medicines may only be used on individuals for whom that medicine is prescribed.2

Apart from this legislation governing the sharing of prescription medicine, there’s also no federal civil liability protection for Good Samaritans rendering bystander emergency first aid; rather, such assistance is governed by a confusing patchwork of civil liability laws that vary from state to state.

It’s unclear how a lack of perceived liability protection may influence bystanders when deciding whether or not to render anaphylaxis first aid. However, such concerns may limit access to community-based emergency epinephrine, as evidenced by a recent anaphylaxis fatality involving a teenager denied epinephrine by a pharmacist in Dublin, Ireland.3

We believe that first aid for anaphylaxis should be rendered using any available epinephrine, and that individuals willing to help should be protected through consistent and inclusive federal legislation. This would involve not only liability legislation but also amendment to the FD&C Act to allow emergency sharing of epinephrine. Such legislation may create wider epinephrine availability, remove perceived legal barriers to the provision of emergency first aid, and ultimately save lives.

In 1992, a landmark study evaluating fatal and near-fatal anaphylactic reactions to foods in children and adolescents over a 14-month period demonstrated why epinephrine availability is critical. Six of 13 patients died, with only two of these patients receiving epinephrine in the first hour. Of the patients who survived, all but one received epinephrine within 30 minutes, suggesting delayed epinephrine administration increases the risk of anaphylaxis fatality.4

Although it’s important to have epinephrine available, it’s often not there when needed. For example, only about 60% of patients in high school actually have epinephrine available at all times.5

As illustrated in this case report, there are times that even diagnosed patients forget to carry their devices. Allergic but undiagnosed individuals have no reason to carry epinephrine. Furthermore, timely access to epinephrine isn’t guaranteed by activating EMS—EMTs and even paramedics may not have access to epinephrine in the field due to jurisdictional prehospital practice variation.

In this case, the mother used her son’s auto-injectors because the BLS provider didn’t have epinephrine. When ambulance arrival and medical treatment was delayed, her husband ran to their nearby home and retrieved an additional EpiPen Jr twin-pack, which allowed administration of two additional epinephrine doses.

The only federal law to promote community anaphylaxis preparedness is the School Access to Emergency Epinephrine Act. Passed in November 2013, this law provides preferences to states that allow self-administration of emergency anaphylaxis medications and legal protection to trained school personnel who administer epinephrine.

It also gives financial incentives to states that require elementary and secondary schools to maintain a supply of epinephrine in an easily accessible and secure location.

Today, nearly every state has passed legislation regarding stocking undesignated epinephrine in K-12 schools; however, only a minority of states actually require it.6

States have been very active over the past few years in working to address the lack of additional federal legislation for access to community-based first-aid epinephrine (i.e., epinephrine sharing). Four states have passed laws that allow, but don’t require, colleges and universities to stock undesignated epinephrine and 30 states allow public venues to stock undesignated epinephrine; however, definitions of what constitutes a venue vary.6

At least one state has gone so far as to allow undesignated epinephrine prescriptions and civil liability protection for businesses and members of the general public who have proper training and certification.7 However, in all cases where states allow public undesignated epinephrine to be prescribed, the laws differ in regard to civil liability and training requirements.

Although progress has been made in improving the availability of undesignated epinephrine, the limitations are still significant, and state laws are inconsistent as they apply to civil liability. Ironically though, epinephrine is commonplace—literally hiding in people’s pockets and purses.

Although the recent controversy surrounding epinephrine cost may discourage individuals from rendering voluntary emergency aid, we suspect most wouldn’t hesitate to save a life using epinephrine prescribed to someone else in an emergency.

In the case presented, after the emergency was resolved, bystanders commented about the cost of the shared epinephrine auto-injectors, but the mother giving aid replied it wasn’t a factor in her decision-making.

Emergency sharing of epinephrine can be lifesaving and Good Samaritans who attempt to assist others experiencing an anaphylactic emergency should be protected. AP Photo/Stephen Morton

Conclusion

If a person experiences anaphylaxis and doesn’t have his or her prescribed epinephrine, either because he or she has never been diagnosed with an allergy, forgot to carry it, or some other reason, their situation is frightening. Such a thought causes heartfelt anxiety in people with severe allergies and their families.

Federal legislation permitting the use of any available epinephrine, whether designated or undesignated, is needed to help ensure epinephrine is available when and where it’s needed. Likewise, federal civil liability legislation is needed to ensure that those Good Samaritans who attempt to assist others experiencing an anaphylactic emergency are consistently protected whenever and wherever they render aid.

Given that this particular healthcare issue is bipartisan in nature and easily addressed, we strongly encourage this change.

References

1. Simons FER, Ardusso LR, Bilo MB, et al. World Allergy Organization guidelines for the assessment and management of anaphylaxis: Summary. J Allergy Clin Immunol. 2011;127(3):587–593.e1–22.

2. The Federal Food, Drug, and Cosmetic Act, as amended, 21 U.S.C § 301 et seq.

3. Farsaci L. (Dec. 10, 2015.) Pharmacist who refused EpiPen for tragic allergy teen is cleared. Irish Independent. Retrieved Aug. 13, 2017, from www.independent.ie/irish-news/courts/pharmacist-who-refused-epipen-for-tragic-allergy-teen-is-cleared-34274984.html.

4. Sampson HA, Mendelson L, Rosen J. Fatal and near-fatal anaphylactic reactions to foods in children and adolescents. N Eng J Med. 1992;327(6):380–384.

5. Sampson HA, Munoz-Furlong A, Sicherer SH. Risk-taking and coping strategies of adolescents and young adults with food allergy. J Allergy Clin Immunol. 2006;117(6):1440–1445.

6. Food Allergy Research and Education. Retrieved July 14, 2017 from www.foodallergy.org.

7. Epinephrine auto-injector information. (n.d.) California Emergency Medical Services Authority. Retrieved July 21, 2017, from www.emsa.ca.gov/Epinephrine_Auto_Injector.