Epinephrine Auto-Injectors (epi-pen)
|Bureau of EMS Policy Statement|
|Policy Statement #||11-08|
|Subject||Epinephrine Auto-Injectors (epi-pen)|
The purpose of this policy is to assist a children's camp or EMS agency in understanding the notification process for utilizing epinephrine auto-injectors under the provisions of Article 30, section 3003 of the Public Health Law authorizing the use of an epinephrine auto-injector (epi-pen). An epinephrine auto-injector program is designed to encourage greater acquisition, deployment and use of epinephrine auto-injectors at children's camps and EMS agencies around the State in an effort to reduce the number of deaths associated with anaphylaxis [hypersensitivity (as to foreign proteins or drugs) resulting from sensitization following prior contact with the causative agent].
At present, only New York State Department of Health Bureau of Emergency Medical Services (BEMS) certified ambulance services are required to have epinephrine auto-injectors and trained providers available when in-service. The exception to this rule is when the ambulance is staffed at the time of the call with an EMT -Critical Care or EMT-Paramedic authorized by the appropriate Regional Emergency Medical Advisory Committee (REMAC) to administer epinephrine via subcutaneous or intramuscular injection. All other recognized EMS agencies such as certified Advanced Life Support First Responder (ALSFR) agencies, Basic Life Support First Responder (BLSFR) agencies with a BEMS issued agency code and children's camps as defined by subpart 7-2 of the New York State Sanitary Code are strongly encouraged to participate in the epinephrine auto-injector program.
To be authorized to purchase, acquire, possess and use an epinephrine auto-injector under this statute, the entity is required to file a completed and signed Notice of Intent to Provide Epinephrine Auto-Injector (NOI) DOH-4188 and collaborative agreement with the appropriate Regional Emergency Medical Services Council (REMSCO) who will then forward a copy of the NOI to BEMS.
There are no approvals or certifications issued by REMSCO/REMAC/BEMS.
Epinephrine Auto-Injector Program Requirements
Original Notification Process
To be authorized to purchase, acquire, possess and utilize an epinephrine auto-injector, the following steps must be completed:
- Identify a New York State licensed physician or New York State based hospital knowledgeable and experienced in emergency cardiac care to serve as Emergency Health Care Provider (EHCP) and participate in a collaborative agreement;
- Select and utilize the appropriate New York State Emergency Medical Services Council (SEMSCO)/BEMS approved epinephrine auto-injector training course curricula for epinephrine auto-injector providers. At present, the two (2) approved curricula are as follows (see attached):
- NYS DOH BEMS EMT-Basic original curriculum (EMT/AEMT providers)
- NYS DOH BEMS Training Program Outline for unlicensed/uncertified personnel (children's camp)
- Other curricula as approved on a case to case basis by NYS DOH Bureau of Community Environmental Health & Food Protection
- Develop with the EHCP, a written collaborative agreement which must include, but not be limited to the following:
- written policy and procedure for 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 notifying the EHCP of the use of the epinephrine auto injector;
- documentation of the use of the epinephrine auto injector;
- Provide written notice to the 911 public safety answering point (PSAP) or equivalent ambulance dispatch entity of the availability of epinephrine auto-injectors at your location
- File with the appropriate REMSCO a completed and signed original of the NOI along with a completed and signed original of the Collaborative Agreement
- File a new NOI and Collaborative Agreement with the REMSCO if the EHCP changes or with a change in content of the Collaborative Agreement
REMSCO Responsibility With Regard To Epinephrine Auto-Injector Programs
Each REMSCO is responsible for receiving and maintaining notification and utilization documentation submitted by the epinephrine auto-injector program. The REMSCO shall develop and implement the following policies and procedures:
- Ensure that a copy of each original or updated NOI is forwarded to BEMS;
- Maintain the original of the NOI and the Collaborative Agreement;
- Collect utilization documentation and information;
- Provide detailed quarterly reports to BEMS regarding epinephrine auto-injector programs in the region, and;
- Develop Continuous Quality Improvement (CQI) participation, data submission and documentation requirements for participating entities.
Data Collection Requirements
The following minimum data shall be developed and collected as a part of the REMSCO epinephrine auto-injector CQI process:
- Name of entity providing the epinephrine auto-injector;
- Date of incident;
- Time of Incident;
- Patient age;
- Patient gender;
- Number of epinephrine auto-injections administered to the patient;
- Name of the transporting ambulance service, and
- Patient status at time of transport
A copy of the data set shall be provided quarterly to BEMS by the REMSCO.
Reporting an Epinephrine Auto-Injector Use
In the event that an epinephrine auto-injector is administered to a patient experiencing anaphylaxis, the entity must report the incident to their EHCP. While it is not required by Article 30 of Public Health Law (PHL), BEMS policy dictates that epinephrine auto-injector entities provide written notification to the REMSCO within 48 hours of the epinephrine auto-injector use. 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 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.
A copy of the above written notification shall also be provided to the EHCP.
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.