Legislation Aims to Protect Children With Severe Allergies

February 3, 2021
Kaitlyn K. Frick

,
Joseph L. Fink III, JD, DSC (Hon.), BSPHARM, FAPhA

Pharmacy Times, January 2021, Volume 89, Issue 1

Push continues for more access to EpiPens, but it is important to protect health care providers who administer the treatment.

Anaphylaxis is the life-threatening allergic reaction to a drug, food, or toxin.1

This reaction is characterized by coughing or wheezing, difficulty breathing, and swelling of the throat, along with other symptoms.2 The symptoms can lead to constricted airways to the lungs, a dangerous lowering of blood pressure, and shock, which can lead to suffocation by swelling of the throat.2 In the United States, the FDA estimates that anaphylaxis caused by food accounts for 30,000 emergency department visits, 2000 hospitalizations, and 150 deaths each year.3

Anaphylaxis and its symptoms can be paused by using an epinephrine automatic injector (EAI), commonly known by the brand name EpiPen.4 The epinephrine mimics adrenaline within the body, opening the airways to the lungs and often preventing death.4 Most people with known food allergies carry an EAI with them at all times, with additional EAIs in places they commonly eat, such as at home, school, or work. Recent legislation has focused on stocking EAIs prescribed to the school, not to an individual child, to assure access to the lifesaving medication during anaphylaxis.5

In November 2013, then-President Barack Obama signed Senate Bill 1503/House of Representatives Bill 2094 into Public Law 113-48.5 This law encouraged states to pass legislation giving trained school officials access to EAIs by giving states that passed these laws preference in federal grants.5 Additionally, it recommended that states ensure civil liability protection to the school personnel giving the EAI so long as it was warranted by the symptoms shown by the student.5 Before this legislation was enacted, school nurses occasionally had to risk their licensure to treat a student without diagnosed food allergies in anaphylaxis with an EAI that was prescribed to another student.2 Federal law prohibits the use of a prescription medication on a person for whom that medication was not prescribed.2 The civil liability protection was written in to protect school nurses from this dilemma.2

A further legal twist is that the Rehabilitation Act of 1973 and the Americans with Disabilities Act of 1990 define a disability as “an impairment that limits a major life activity.”3-6

In the case of a severe allergic reaction, 3 major life activities could be threatened: breathing, caring for oneself, and eating. A parent of a child prone to such reactions has the right to request that the school have in place a documented plan regarding how teachers and other staff members will address avoidance and treatment of anaphylaxis.3

As of 2016, 46 states had passed legislation to authorize stocking EAI at schools; 3 have legislation pending.5 As states moved toward allowing EAI in schools, many districts ran into difficulties finding a physician who would prescribe the EAI and take on the liability of its use within the school.2

For example, in California, Senate Bill 1266 described its protection of school personnel using the EAI in good faith and authorized training and prescriptions to be written to schools.2 In California, the legislation authorized pharmacists to dispense EAI to school personnel who have the training outlined in the bill.2

But that legislation did not protect the physicians who issued the prescriptions.2 Because this was not written into the legislation, any physician who chose to prescribe an EAI to a school may have had to purchase additional malpractice insurance coverage.2 Some states have worked to protect these physicians with an additional bill. In California, Senate Bill 738 was signed into law in July 2015.7 This law protects the physician from professional review, civil action, or criminal prosecution for prescribing an EAI to a school.7

Following the implementation of these laws, food allergy advocates began to work toward legislation that increases the “authorized entities” in which EAIs can be prescribed.6 In California, Assembly Bill 1386, signed into law in 2016, expanded the locations where EAIs could be prescribed to any public space where food is present.8 This could include amusement parks, movie theaters, sports arenas, or summer camps.8 As of April 6, 2020, 37 states have passed similar laws to allow other public venues to have an EAI on location at all times.5

Mylan has implemented a program through which the manufacturer will provide up to 4 EAIs to a school, private or public, with students in kindergarten through high school.1 Additionally, the CDC has prepared voluntary guidelines recommending that school officials have in place a policy for avoiding allergic triggers, managing food allergies, and taking appropriate emergency action if an allergic emergency arises.1

Although food allergy advocates continue to push for more access to EAIs, it is important to protect physicians, pharmacists, and trained personnel who administer EAIs. Having EAIs in public schools and other public areas can prevent deaths of individuals with food allergies.3 Preventing death from anaphylaxis started with the federal public law in 2013 and has since expanded throughout the country.5

KAITLYN K. FRICK is a recent graduate of the University of Kentucky College of Health Sciences in Lexington with a major in human health sciences. She is enrolled in the MD/MPH degree program at Southern Illinois University in Carbondale.JOSEPH L. FINK III, JD, DSC (HON.), BSPHARM, FAPHA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.

REFERENCES

  • CDC. Voluntary guidelines for managing food allergies in schools and early care and education programs. 2013. Accessed December 17, 2020. https://www.cdc. gov/healthyschools/foodallergies/pdf/13_243135_a_ food_allergy_web_508.pdf
  • Adams JM. Schools require emergency allergy medicine, but doctors balk. EdSource. May 27, 2015. Accessed December 17, 2020. https://edsource. org/2015/schools-require-emergency-allergy-medicine- but-doctors-balk/80214
  • Moses M, Gilchrest C, Schwab NC. Section 504 of the Rehabilitation Act: determining eligibility and implications for school districts. J Sch Nurs. 2005;21(1):48- 58. doi:10.1622/1059-8405(2005)021
  • EpiPen. Mylan. Accessed December 17, 2020. www. epipen.com
  • Asthma and Allergy Foundation of America. Epinephrine in Schools. Accessed December 17, 2020. https:// www.aafa.org/epinephrine-stocking-in-schools/
  • Allergy and Asthma Network. Laws to protect those with asthma and allergies. Accessed December 17, 2020. https://www.allergyasthmanetwork.org/advocacy/ current-issues/stock-epinephrine-entity-laws/
  • Pupil health: epinephrine auto-injectors: liability limitation. Senate Bill No. 738, Chapter 132 (2015).
  • Emergency medical care: epinephrine auto-injectors. Assembly Bill No. 1386, Chapter 374 (2016).