Epinephrine Auto-Injectors (EpiPen®)

Bureau of Emergency Medical Services
Policy Statement # 17-02
Date March 13, 2017
Subject Epinephrine Auto-Injectors (EpiPen®)
Supercedes/Updates 00-01, 00-02, 11-08 & 14-02

The purpose of this policy is to assist eligible entities defined by Article 30, section 3000-c of the Public Health Law (PHL) in understanding the notification process for utilizing epinephrine auto-injectors (i.e. EpiPen®). An epinephrine auto-injector program is designed to encourage greater acquisition, deployment and use of epinephrine auto-injectors in an effort to reduce the number of deaths associated with anaphylaxis.

An "epinephrine auto-injector device" is defined as a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body, approved by the U.S. Food and Drug Administration for the purpose of emergency treatment of a person appearing to experience anaphylactic symptoms.

Eligible entities are defined as:

  1. An ambulance service or advanced life support first response service; a certified first responder, emergency medical technician, advanced emergency medical technician or paramedic, who is employed by or an enrolled member of any such service;
  2. A children's overnight camp as defined in subdivision one of section thirteen hundred ninety-two PHL, a summer day camp as defined in subdivision two of section thirteen hundred ninety-two of PHL, a traveling summer day camp as defined in subdivision three of section thirteen hundred ninety-two of PHL or a person employed by such a camp;
  3. School districts, boards of cooperative educational services, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in this state or any person employed by any such entity;
  4. A sports, entertainment, amusement, education, government, day care or retail facility; an educational institution, youth organization or sports league; an establishment that serves food; or a person employed by such entity; and
  5. Any other person or entity designated or approved, or in a category designated or approved pursuant to regulations of the commissioner in consultation with other appropriate agencies.
  6. New York State EMS agencies with a Department issued agency code; children's camps as defined by subpart 7-2 of the New York State Sanitary Code; and schools are strongly encouraged to participate in the epinephrine auto-injector program.

New York State EMS agencies with a Department issued agency code; children's camps as defined by subpart 7-2 of the New York State Sanitary Code; and schools are strongly encouraged to participate in the epinephrine auto-injector program.

Epinephrine Auto-Injector Program

To initiate an epinephrine auto-injector program, the following steps should be considered:

  • A health care practitioner or pharmacist authorized to prescribe medications may prescribe, dispense or provide an epinephrine auto-injector device to or for an eligible person or entity by a non-patient-specific prescription.
  • Select and successfully complete a training course in the use of epinephrine auto-injector devices conducted by a nationally recognized organization experienced in training laypersons in emergency health treatment, by using the Training Guidelines (https://health.ny.gov/professionals/ems/pdf/epi_auto-inject_training_guidelines.pdf) or by a program approved by the Commissioner of Health.
    Any training program submitted for approval must include, but may not be limited to the following objectives and competencies:
    1. identify common causes of allergic reactions;
    2. identify the signs and symptoms of a mild and severe allergic reaction (anaphylaxis);
    3. identify how signs and symptoms of anaphylaxis differ from other medical conditions;
    4. demonstrate knowing when epinephrine should be administered and when it should not be administered;
    5. demonstrate determining the correct dose of auto-injector, adult or pediatric, to administer;
    6. demonstrate the steps for administering epinephrine by an auto-injector;
    7. describe the methods for safely storing and handling epinephrine and appropriately disposing of the auto-injector after use;
    8. demonstrate the steps for providing for on-going care of the patient until Emergency Medical Services (EMS) arrives;
    9. demonstrate knowledge of appropriate documentation and reporting of an event in which an epinephrine auto-injector was administered; and
    10. understand the NYS laws that allow an individual to possess and use an epinephrine auto-injector in a life-threatening situation.
  • Prior to initiating the training program, please submit proposed training programs for approval to:
    • New York State Department of Health
      Bureau of Emergency Medical Services and Trauma Systems
      875 Central Avenue
      Albany, NY 12206

      518-402-0996
      518-402-0985 (fax)
  • Suggested policies and procedures:
    • Written policies and procedures for the acquisition, storage, accounting, and proper disposal of used auto-injectors.
    • Written policies and procedures for the training of authorized users;
    • Written practice protocols for the use of the epinephrine auto-injector;
    • A method of making notification of the use of the epinephrine auto-injector;
    • A method for documentation of the use of the epinephrine auto-injector; and
    • A process for quality assurance.

Reporting an Epinephrine Auto-Injector Use

In the event that an epinephrine auto-injector is administered to a patient experiencing anaphylaxis, the entity should report the incident. At a minimum, the following should be provided as part of this written notification:

  • The name of the epinephrine auto-injector entity;
  • Location of the incident;
  • The date and time of the incident;
  • The age and gender of the patient;
  • The number and dose of epinephrine auto-injectors administered to the patient:
  • The name of the ambulance service that transported the patient, and
  • The name of the hospital to which the patient was transported.

In the case of an EMS agency, the report must be written and submitted on a Prehospital Care Report (PCR/e-PCR) and shared with the agency's physician medical director.

In addition, Subpart 7-2 of the State Sanitary code requires children's camp operators to report in writing any epinephrine administration to the permit-issuing official within 24 hours of the administration.

Resources

Chapter 373 of the Laws of 2016 - effective March 28, 2017