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17-02 Epinephrine Auto-Injectors Page 1 of 3 New York State Department of Health Bureau of Emergency Medical Services POLICY STATEMENT Supersedes/Updates: 00-01, 00-02, 11-08 & 14-02 No. 17-02 Date: March 13, 2017 Re: Epinephrine Auto-Injectors (EpiPen®) Page 1 of 3 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 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. 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. ---PAGE BREAK--- 17-02 Epinephrine Auto-Injectors Page 2 of 3 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 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 of a mild and severe allergic reaction (anaphylaxis); 3. identify how signs and 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 [PHONE REDACTED] [PHONE REDACTED] (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. ---PAGE BREAK--- 17-02 Epinephrine Auto-Injectors Page 3 of 3 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 New York State Public Health Law, Article 30, section 3000-c http://www.health.ny.gov/professionals/ems/art30.htm#BM3000c Epinephrine by Auto-Injector Training Guidelines for Unlicensed or Uncertified Personnel EMT original curriculum Lesson 4-5 on Allergies http://www.health.ny.gov/professionals/ems/national_education_standards_transition/docs/nys_e mt_education_standards.pdf American Academy of Pediatrics http://www.aap.org American Red Cross - Anaphylaxis and Epinephrine Auto-Injector - Online Course http://www.redcross.org/take-a-class/course-dowbt000000000011096 American College of Allergy, Asthma & Immunology http://acaai.org/ Food Allergy Research and Education Asthma and Allergy Foundation http://www.aafa.org/ Regional EMS Council Listing http://www.health.ny.gov/professionals/ems/regional.htm Chapter 373 of the Laws of 2016 - effective March 28, 2017