Administration of Epinephrine Auto-Injectors

Training Standards for the Administration of Epinephrine Auto-Injectors

Contents

Introduction | Training Standards | Guidelines for School Districts | Relevant Laws | Resources | Acknowledgements

I. Introduction

Anaphylaxis is a potentially life-threatening hypersensitivity to a substance.1 The reaction can occur within seconds or minutes of encountering an allergic trigger, including but not limited to an insect sting, food allergy, drug reaction (e.g., antibiotics, aspirin and non-steroidal inflammatory drugs), and exercise.2 Other causes include latex and, less commonly, food-dependent, exercise-induced anaphylaxis and idiopathic anaphylaxis (unknown cause). Symptoms may include shortness of breath, wheezing, difficulty breathing, difficulty talking or swallowing, hives, itching, swelling (of the face, lips, tongue, or other parts of the body), shock, or asthma.3 Other symptoms may include narrowing of the airways, rashes, hoarseness, nausea or vomiting, weak pulse, and dizziness. Individuals may experience anaphylaxis and not show any skin symptoms. Many individuals may have previously had only a mild reaction to an allergen, but subsequent exposure can trigger anaphylaxis. Without immediate administration of epinephrine followed by activation of emergency medical services, death can occur.

According to Centers for Disease Control and Prevention (CDC),4 anaphylaxis affects one in every 13 children (under eighteen years of age) or approximately two children in every classroom. It is estimated that 25 percent of students have their first anaphylactic reaction at school.

California Education Code (EC) Section 49414, as amended by Senate Bill 1266, effective January 1, 2015,5 requires school districts to provide emergency epinephrine auto-injectors to school nurses or trained personnel who have volunteered, and provides that school nurses or trained designated personnel who have volunteered may use epinephrine auto-injectors to provide emergency medical aid to persons suffering or reasonably believed to be suffering from an anaphylactic reaction.6 The legislative history of SB 1266 indicates the intent to protect not only children with previously diagnosed allergies, but also children who do not know they are allergic and who therefore may not have prescribed epinephrine.7 The law requires the State Superintendent of Public Instruction (SSPI) to review and update the minimum training standards for the administration of epinephrine auto-injectors at least every five years,8 and requires a school district, county office of education, or charter school to annually distribute a volunteer request and description of training.9

This document updates previous minimum training standards for the administration of epinephrine auto-injectors in accordance with EC Section 49414. These updated training standards were developed in consultation with organizations and providers with expertise in administering epinephrine auto-injectors and administering medication in a school environment, as required by EC Section 49414(e)(1).

Local educational agencies may also wish to consult their own attorneys.

II. Training Standards

Schools may designate one or more volunteers to receive initial and annual refresher training, based on the standards developed by the SSPI, regarding the storage and use of an epinephrine auto-injector from the school nurse or another qualified person designated by an authorizing physician.10 Training should include the following information:

1. Techniques for Recognizing Symptoms of Anaphylaxis
2. Standards and Procedures for Emergency Use and Storage of Epinephrine Auto-Injectors
3. Emergency Follow-up Procedures
4. Recommendations on Necessity of Instruction and Certification in Cardiopulmonary Resuscitation (CPR)
5. Instruction on How to Determine Whether to Use an Adult Epinephrine or a Junior Epinephrine Auto-injector
6. Written Materials Covering the Information Above11
   
   

A. Techniques for Recognizing Symptoms of Anaphylaxis12

The signs and symptoms of anaphylaxis usually appear rapidly, within seconds or minutes after allergen exposure, although in some cases the reaction can be delayed for up to several hours. Anaphylaxis is highly likely to be occurring when any ONE of the following happens within minutes to hours after exposure to an allergen:

1. A person has symptoms that involve the skin, nose, mouth, or gastrointestinal tract
   • Itching, wheezing, swelling, throat tightening, vomiting, or diarrhea
     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 (known allergy) allergen, and TWO or more of the following symptoms occur:
   • Skin symptoms or swollen lips (itchy mouth or hives)
   • Difficulty breathing
   • Reduced blood pressure
   • Gastrointestinal symptoms (e.g., vomiting, diarrhea, or cramping)

For some individuals who have had an anaphylactic reaction, the symptoms may go away but then return a few hours later. This is called a bi-phasic reaction. Often the symptoms of the bi-phasic reaction occur in the respiratory system and take the individual by surprise. Therefore, according to the American Academy of Allergy, Asthma and Immunology (AAAAI),13 after a serious reaction “observation in a hospital setting is necessary for at least four hours after initial symptoms subside because delayed and prolonged reactions may occur even after proper initial treatment.” Individuals may require a longer observation stay in the emergency department and/or may be admitted to the hospital for additional treatment and evaluation.

B. Standards and Procedures for Emergency Use and Storage of Epinephrine Auto-Injectors14

1. Storage and restocking. An epinephrine auto-injector is a disposable drug delivery system with a spring activated needle that is designed for emergency administration of epinephrine to provide rapid, convenient first aid for persons suffering a potentially fatal reaction to anaphylaxis.15 This ready-to-use and easily transported system is designed to treat a single anaphylactic episode. It must be properly discarded (in compliance with applicable state and federal laws) after its use, or provided to the emergency medical responders.
   
   A qualified supervisor of health, which may include but is not limited to a school nurse16 (or, if there is no qualified supervisor of health, an administrator)17 shall obtain from an authorized physician18 a prescription for each school for epinephrine auto-injectors that, at a minimum, includes one regular (or adult) and one junior epinephrine auto-injector for an elementary school, and one regular or adult (if there are no pupils requiring a junior) epinephrine auto-injector for a junior high school, middle school or high school19 (it is generally recommended that two epinephrine auto-injectors be kept on-hand, as back-up).
   
   The qualified supervisor of health (or administrator) shall be responsible for stocking the epinephrine auto-injector and restocking it if it is used.20 If the epinephrine auto-injector is used it shall be restocked as soon as reasonably possible, but no later than two weeks after it is used.21 Epinephrine auto-injectors shall be restocked before their expiration date.22
   
   According to the manufacturer, epinephrine auto-injectors should be stored in a secure but accessible, well-marked location, at room temperature until the marked expiration date, at which time the unit must be replaced. Auto-injectors should not be refrigerated as this could cause the device to malfunction. Epinephrine auto-injectors should not be exposed to extreme heat or direct sunlight. Heat and light shorten the life of the product and can cause the epinephrine to degrade. To be effective, the solution in the auto-injector should be clear and colorless. If the solution is brown, the unit should be replaced immediately.23
   
   A state agency, the department, or a public school may accept gifts, grants, and donations from any source for the support of the public school carrying out the provisions of this section, including, but not limited to, the acceptance of epinephrine auto-injectors from a manufacturer or wholesaler.24 A pharmacy may furnish epinephrine auto-injectors to a school district, county office of education, or charter school for its exclusive use upon a physician’s written order specifying the quantity to be furnished.25 The school district, county office of education, or charter school is responsible for monitoring the supply of epinephrine auto-injectors received from a pharmacy and ensuring that they are destroyed when expired.26
   
   
2. Emergency use. A school nurse, or, if the school does not have a school nurse or the school nurse is not on-site or available, a trained volunteer27 may administer an epinephrine auto-injector to a person exhibiting potentially life-threatening symptoms of anaphylaxis at school or a school activity when a physician is not immediately available.28 The following information on the emergency use of an epinephrine auto-injector is based on the manufacturer's instructions29 and represents the consensus recommendations of the organizations and providers consulted per EC Section 49414(e)(1). Once anaphylaxis symptoms are present, it is recommended that the first line of treatment of choice is an immediate intramuscular injection of epinephrine (epinephrine auto-injector) injected into the lateral (outer side) thigh, which is effective for five minutes (according to the manufacturer of epinephrine auto-injectors).
   
   Steps in the Emergency Use of an Epinephrine Auto-Injector:
   
   
   1. Determine if anaphylaxis is suspected. Anaphylaxis usually, but not always, occurs right after exposure to an allergen. Frequently, anaphylaxis occurs in individuals who have a history of a previous reaction. If there is uncertainty about the diagnosis, but there is a reasonable probability that it is anaphylaxis, then treat as anaphylaxis.
      
      
   2. If anaphylaxis symptoms occur, administer the epinephrine auto-injector then call 911 or activate the emergency medical system (EMS). Stay with the individual experiencing anaphylaxis. Have others notify the paramedics, school nurse, parents and school administrator immediately.30
      
      
   3. Dosage:
      1. For students in second grade or below, or weighing 33-66 lbs., administer 0.15 mg., epinephrine auto-injector (Junior) (when in doubt-give the higher dose) by injecting it into the lateral (outer side) thigh.
      2. For adults and students in third grade or above, or weighing 66 lbs. or more, administer 0.30 mg., epinephrine auto-injector (Adult) by injecting it into the lateral (outer side) thigh.
         
         
   4. Stay with the individual and reassure them. Do not raise them to an upright position. Have the individual lie down if tolerated with lower extremities elevated. Roll the individual to their side if vomiting. Have them sit up if they have difficulty breathing.
      
      
   5. Epinephrine auto-injector administration procedure:
      
      Read the manufacturer’s instructions regarding administration of epinephrine auto-injector.
      1. Remove safety cap or cover of epinephrine auto-injector and place ‘tip’ (“active side of device”) on outside of thigh—midway between hip and knee (follow instructions—may require pressure while placing on thigh)
      2. Position device perpendicular (90 degree angle) to the thigh
      3. It can be administered through clothing
      4. Wait for click or other sound indicating medication is being administered
      5. Hold in place for approximately 3 seconds (or as recommended by the manufacturer’s instructions)
      6. Many have a shield that covers the exposed needle
      7. Keep epinephrine auto-injector until emergency personnel arrive. Per their direction, either give to them or place expended injector in sharps container
         
         
   6. If the anaphylactic reaction is due to an insect sting, remove the stinger as soon as possible after administering the epinephrine auto-injector. Remove stinger quickly by scraping with a fingernail, plastic card, or piece of cardboard. Apply an ice pack to the sting area. DO NOT push, pinch, or squeeze, or further imbed the stinger into the skin because such action may cause more venom to be injected into the individual.
   7. Observe the affected individual for signs of shock. Cover them with a blanket, as necessary, to maintain body temperature and help to prevent shock
   8. Monitor the affected invididual's airway, breathing, and heart rate. Begin CPR immediately if the individual stops breathing or their heart stops beating.
      • If symptoms continue or worsen and paramedics have not arrived, use a second epinephrine auto-injector and re-inject no less than 5 minutes after initial injection. Continue to monitor the individual's airway and breathing.
   9. After epinephrine is given, the individual should be promptly taken to the nearest emergency department by ambulance for evaluation and monitoring by physicians and nurses. A second delayed reaction may occur after the initial anaphylaxis and this second set of symptoms can also be severe and life-threatening. After evaluation and treatment in the emergency department, parents/guardians should be advised to monitor student according to recommendations of the treating healthcare provider(s) and staff should be informed by the treating healthcare provider on next steps for safe care.
   10. Document the incident, complete and submit any required reporting forms to the appropriate staff. Include in the documentation the date and time epinephrine auto-injector was administered, the individual’s response, and additional pertinent information.
       
       

C. Emergency Follow-up Procedures31

After administering the epinephrine auto-injector, immediately have someone call 91132 to activate the EMS. Stay with the individual. Have others notify the paramedics, school nurse, and school administrator immediately. If possible, contact the pupil’s parent and physician.33 Promptly transfer the individual to the nearest emergency department via ambulance for additional evaluation, monitoring, and treatment by physicians and nurses.

D. Recommendations on the Necessity of Instruction and Certification in Cardio-Pulmonary Resuscitation34

Training in CPR is recommended. Any designated school personnel volunteering to be trained to administer epinephrine auto-injectors should be encouraged to receive CPR training.

E. Instruction in How to Determine Whether to Use an Adult or Junior Epinephrine Auto-injector.35

According to the manufacturer, for students in second grade or below, or weighing 33-66 lbs., administer 0.15 mg., epinephrine auto-injector (Junior) by injecting it into the lateral (outer side) thigh. (When in doubt, give the higher dose.)

For adults and students in third grade or above, or weighing 66 lbs. or more, administer 0.30 mg., epinephrine auto-injector by injecting it into the lateral (outer side) thigh (Adult).

F. Written Materials

Training must include written materials that cover the information described in A through E above. The school must retain those materials for a period of three years.36, 37

III. Guidelines for School Districts

School districts should consider developing policies and procedures that align with these Training Standards and address topics including, but not limited to: training protocols, emergency care plans, storage, and documentation. The Centers for Disease Control and Prevention recommends developing a school- or district-wide food allergy program; guidelines can be found at Food Allergies Publications and Resources .

School districts shall maintain documentation of the acquisition and disposition of epinephrine auto-injectors received from a pharmacy for three years.37 It is recommended that documentation of all training, including sign-in sheets, training materials, copies of notices describing the volunteer request and training, report of administration of epinephrine auto-injector, and any follow-up documentation be maintained according to the district’s policies and procedures.

IV. Relevant Laws

Business and Professions Code Section 4119.2(a) allows pharmacies to furnish epinephrine auto-injectors to a local educational agency pursuant to EC Section 49414 if the epinephrine auto-injectors are furnished exclusively for use at a school district site or county office of education and a physician and surgeon provides a written order that specifies the quantity of epinephrine auto-injectors to be furnished. Business and Professions Code Section 4119.2(b) requires that records regarding the acquisition and disposition of so furnished epinephrine auto-injectors be maintained by the local educational agency for a period of three years from the date the records were created. Business and Professions Code Section 4119.2(b) also requires the local educational agency to be responsible for monitoring the supply of auto-injectors and assuring the destruction of expired auto-injectors.

EC Section 49414(a) requires a school district, county office of education, or charter school to provide emergency epinephrine auto-injectors to school nurses and trained personnel who have volunteered and authorizes school nurses and trained personnel to use epinephrine auto-injectors to provide emergency medical aid to person suffering, or reasonably believed to be suffering from an anaphylactic reaction.

EC Section 49414(c) allows each private elementary and secondary school to voluntarily determine whether or not to make emergency epinephrine auto-injectors and trained personnel available at the school. EC Section 49414(c) requires a school, in making this determination, to evaluate the emergency medical response time to the school and determine whether initiating emergency medical services is an acceptable alternative to epinephrine auto-injectors and trained personnel.

EC Section 49414(d) allows each public and private elementary and secondary school in the state to designate one or more school personnel on a voluntary basis to receive initial and annual refresher training, based on the minimum training standards developed by the SSPI, regarding the storage and emergency use of an epinephrine auto-injector from the school nurse or other qualified person designated by an authorizing physician and surgeon.

EC Section 49414(e)(1) requires the SSPI to establish minimum standards of training for the administration of epinephrine auto-injectors.

EC Section 49414(e)(2) states that the training standards shall include all of the following:

1. Techniques for recognizing symptoms of anaphylaxis.
2. Standards and procedures for the storage, restocking, and emergency use of epinephrine auto-injectors.
3. Emergency follow-up procedures, including calling the emergency 911 phone number and contacting, if possible, the pupil's parent and physician.
4. Recommendations on the necessity of instruction and certification in CPR.
5. Instruction on how to determine whether to use an adult epinephrine auto-injector or a junior epinephrine auto-injector, which shall include consideration of a pupil’s grade level or age as a guideline of equivalency for the appropriate pupil weight determination.
6. Written materials covering the information required under this subdivision.

EC Section 49414(e)(3) states that training established pursuant to this subdivision shall be consistent with the most recent Voluntary Guidelines for Managing Food Allergies In Schools and Early Care and Education Programs published by the federal Centers for Disease Control and Prevention and the most recent guidelines for medication administration issued by the department.

EC Section 49414(e)(4) requires a school to retain for reference the written materials prepared in compliance with section 49414(e)(2)(F).

EC Section 49414(e)(f) states that a school district, county office of education, or charter school shall distribute a notice at least once per school year to all staff that contains the following information:

(1) A description of the volunteer request stating that the request is for volunteers to be trained to administer an epinephrine auto-injector to a person if the person is suffering, or reasonably believed to be suffering, from anaphylaxis, as specified in subdivision (b).

(2) A description of the training that the volunteer will receive pursuant to subdivision (d).

(3) The location of the epinephrine auto-injectors on campus.

EC Section 49414(g)(1) requires a qualified supervisor of health at a school district, county office of education, or charter school shall obtain from an authorizing physician and surgeon a prescription for each school for epinephrine auto-injectors that, at a minimum, includes, for elementary schools, one regular epinephrine auto-injector and one junior epinephrine auto-injector, and for junior high schools, middle schools, and high schools, if there are no pupils who require a junior epinephrine auto-injector, one regular epinephrine auto-injector. A qualified supervisor of health at a school district, county office of education, or charter school shall be responsible for stocking the epinephrine auto-injector and restocking it if it is used.

EC Section 49414(g)(2) states that if a school district, county office of education, or charter school does not have a qualified supervisor of health, an administrator at the school district, county office of education, or charter school shall carry out the duties specified in paragraph (g)(1).

EC Section 49414(g)(3) states that a prescription pursuant to this subdivision may be filled by local or mail order pharmacies or epinephrine auto-injector manufacturers.38 39

EC Section 49414(h) allows a school nurse or, if the school does not have a school nurse or the school nurse is not on-site or available, a volunteer to administer an epinephrine auto-injector to a person exhibiting potentially life-threatening symptoms of anaphylaxis at school or a school activity when a physician is not immediately available. If the epinephrine auto-injector is used it shall be restocked as soon as reasonably possible, but no later than two weeks after it is used. Epinephrine auto-injectors shall be restocked before their expiration date.

EC Section 49414(i) states that a volunteer shall initiate emergency medical services or other appropriate medical follow up in accordance with the training materials retained pursuant to paragraph (4) of subdivision (e).

EC Section 49414(j) requires a school district, county office of education, or charter school to ensure that each employee who volunteers under this section will be provided defense and indemnification by the school district, county office of education, or charter school for any and all civil liability, in accordance with, but not limited to, that provided in Division 3.6 (commencing with Section 810) of Title 1 of the Government Code. This information shall be reduced to writing, provided to the volunteer, and retained in the volunteer’s personnel file.

V. Resources

American Academy of Allergy, Asthma and Immunology (AAAAI)

American Academy of Pediatrics (AAP)

California Department of Education (CDE)

California Department of Public Health (CDPH)

California Medical Association (CMA)

California School Nurses Organization (CSNO)

Emergency Medical Systems Authority (EMSA)

Epinephrine Standing Order Online Application

Food Allergy and Resource Education (FARE)

Schools at Allergy Home

VI. Acknowledgements

In compliance with the authorizing statute,40 the following individuals and agencies were consulted in the review of the training standards:

• Dawn Anderson, MA, BSN, RN, PHN, RCSN Oxnard Union High School District
• Sheri Coburn, Ed. D., M.S, RN, Director of Comprehensive Health Programs, San Joaquin County Office of Ed
• Joan Edelstein, Dr. PH, RN, Health Services Coordinator, Oakland Unified School District
• Marilyn Glinskas, BSN, RN, PHN, Stanislaus County Office of Education
• Connie Green, Bay Area Food Allergy Network
• Heidi Hannaman, Legislative Aide, Office of Senator Bob Huff
• Travis Miller, MD, FACAAI, FAAP, FAAAI, D-ABIM, Medical Director, The Allergy Station
• Cathy Owens, RN, M.Ed, NCSN, ERSN, California School Nurses Organization
• Anne F. Russell, BSN, RN, AE-C, Food Allergy Specialty Nurse, Faculty Spring Arbor University
• Howard Taras, MD, Medical Specialist School Health, Professor UCSD School of Medicine
• Michael J. Welch, MD, FAAP, FAAAAI, Co-Director, Allergy & Asthma Medical Group and Research Center

1EC Section 49414(b)(1).

2EC Section 49414(b)(1)(B).

3EC Section 49414(b)(1)(A).

4Centers for Disease Control and Prevention: Food Allergies

5Stats. 2014, c. 321, § 2.

6EC Section 49414(a).

7See, e.g., Senate Judiciary Committee Analysis of SB 1266, April 28, 2014.

8EC Section 49414(e)(1).

9EC Section 49414(f).

10EC Section 49414(d).

11EC Section 49414(e)(2).

12EC Section 49414(e)(2)(A).

13American Academy of Allergy, Asthma, and Immunology

14EC Section 49414(e)(2)(B).

15EC Section 49414(b)(3).

16EC Section 49414(b)(4).

17EC Section 49414(g)(2).

18EC Section 49414(b)(2).  An authorized physician may include but is not limited to a physician employed by or contracting with a local educational agency, a medical director of the local health department, or a local emergency medical services director.

19EC Section 49414(g)(1).

20EC Section 49414(g)(1).

21EC Section 49414(h).

22EC Section 49414(h).

23Epi-Pen

24EC Section 49414(k).

25Business and Professions Code Section 4119.2(a).

26Business and Professions Code Section 4119.2(b).

27EC Section 49414(b)(5).

28EC Section 49414(h).

29Epi-Pen

30EC Section 49414(e)(2)(C).

31EC Section 49414(e)(2)(C).

32EC Section 49414(e)(2)(C).

33EC Section 49414(e)(2)(C).

35EC Section 49414(e)(2)(E).

36EC Section 49414(e)(4).

37Business and Professions Code Section 4119.2(b).

38Food Allergies in Schools

39Program Advisory on Medication Administration (PDF)