Stock Epinephrine
MN Statute 121A.2207 Life-Threatening Allergies in Schools: Stock Supply of Epinephrine Delivery Systems
Subdivision 1. Districts and schools permitted to maintain supply.
Notwithstanding section 151.37, districts and schools may obtain and possess epinephrine delivery systems to be maintained and administered by school personnel to a student or other individual if, in good faith, it is determined that person is experiencing anaphylaxis regardless of whether the student or other individual has a prescription for an epinephrine delivery systems. The administration of an epinephrine delivery system in accordance with this section is not the practice of medicine.
(b) Registered nurses may administer epinephrine delivery systems in a school setting according to a condition-specific protocol as authorized under section 148.235, subdivision 8. Notwithstanding any limitation in sections 148.171 to 148.285, licensed practical nurses may administer epinephrine delivery systems in a school setting according to a condition-specific protocol that does not reference a specific patient and that specifies the circumstances under which the epinephrine delivery system is to be administered, when caring for a patient whose condition falls within the protocol.
Subd. 2. Arrangements with manufacturers.
A district or school may enter into arrangements with manufacturers of epinephrine delivery systems to obtain epinephrine delivery systems at fair-market, free, or reduced prices. A third party, other than a manufacturer or supplier, may pay for a school's supply of epinephrine delivery systems.
Subd.3. Standing order for distribution and condition specific protocol.
The commissioner of health must provide a district or school with a standing order for distribution of epinephrine delivery systems under sections 148.235, subdivision 8; and 151.37, subdivision 2.
MN Statute 121A.2205 Possession and Use of Epinephrine Delivery Systems Model Policy
Subdivision 1 (2) defines “epinephrine delivery system" means a device that automatically injects a premeasured dose of epinephrine medication product approved by the United States Food and Drug Administration that automatically delivers a single, premeasured dose of epinephrine to prevent or treat a life-threatening allergic reaction.
- Epinephrine delivery system could include auto injectors or nasal atomizers. Both types of delivery systems are currently available and approved through the Food and Drug Administration.
These statutes allow for but does not require schools to stock and administer epinephrine delivery system for life-threating allergies. Implementation of stock epinephrine delivery system requires several components.
Emergency Response Procedure for Life Threatening Allergic Reaction (Anaphylaxis)
A procedure is a sequence of steps that should be followed to implement policies. This procedure may vary slightly by site even within a school district pending the environment and resources.
Schools are encouraged to consider the following questions for the development of the school’s procedure.
- Who is the population of students, staff, and visitors to be served?
- Where will the emergency response be delivered and where the epinephrine delivery system be secure, accessible, and stored per manufactures direction?
- Which school staff, at the designated location, will be trained to respond and to administer the medication when an emergency response is needed? Who else should be a part of the emergency response team, besides the person trained to the given the medication?
- Consider when the trained staff will be available to provide this emergency response. During the school day only? During other after school hour events?
- How staff will be initially trained and remain competent in the knowledge to identify a possible a life threatening allergic response, know, and administer the medication appropriately, and initiate?
- What type of communication, notification, and documentation will need to be completed as part of the emergency response and medication administration?
Epinephrine Medication
The Allergy & Asthma Network provides valuable information about epinephrine.
An anaphylactic reaction causes life-threatening symptoms. If not quickly treated, these symptoms can lead to anaphylactic shock and death. When epinephrine is administered, it triggers a sudden burst of adrenaline to multiple areas of the body at the same time. It works by reducing throat swelling. It opens the airways. It helps maintain heart function and blood pressure. Also, as epinephrine can help reduce hives and itching. Epinephrine will also prevent a further release of histamine, the chemical that responds to allergens and ushers in symptoms.
Epinephrine use in anaphylaxis reduces or reverses these severe symptoms immediately, but the full effect may take 5-10 minutes. Epinephrine begins wearing off within 20-30 minutes. Therefore, 911 must be called because additional emergency care may be needed after administering epinephrine.
Epinephrine auto injectors or nasal atomizers are a prescribed medication and are single dose. This means once given, the delivery system is empty and cannot be used again.
Epinephrine is so effective it reverses the life-threatening allergic reaction, but it is not without potential side effects. A true allergy to epinephrine is extremely rare. Side effects may include:
- Trouble breathing
- Fast, irregular, or pounding heartbeat
- Pale skin
- Sweating
- Nausea and/or vomiting
- Dizziness
- Weakness or tremors
- Headache
- Anxiety or restlessness
Most side effects will resolve in about 30 minutes and fully disappear within a few hours. This is another reason 911 must be called if administered.
Recognizing Signs and Symptoms of Anaphylaxis
Anaphylaxis is diagnosed when symptoms appear on two or more body organ systems. Anaphylaxis symptoms involve:
- Skin: itching, redness, swelling, hives that are widespread across the body
- Mouth and/or throat: itching, swelling of lips or tongue
- Stomach: vomiting, diarrhea, cramps
- Respiratory: trouble breathing, shortness of breath, wheezing, coughing, chest pain and/or tightness
- Heart: weak pulse, dizziness, faintness
- Headache, nasal congestion, watery eyes, sweating
- Confusion, feeling of impending doom
- Loss of consciousness
Resources for Obtaining Epinephrine Delivery Systems
Epinephrine is a medication that requires a prescription. This means that a licensed prescriber will need to provide a prescription (order) so that the school may obtain or purchase epinephrine.
The EpiPen™4 Schools program offers Four free EPIPEN® (epinephrine injection, USP) or EPIPEN JR® (epinephrine injection, USP) Auto-Injectors in the form of two EPIPEN 2-PAK® cartons, two EPIPEN JR 2-PAK® cartons or one 2-Pak of each kind. The school must submit a valid prescription from a licensed prescriber to qualify for this program.
The neffyinSchools program offers two cartons (four single use doses) of neffy® for all public and private K12 schools in the U.S.
Note: As a condition of participation in the neffyinSchools program, districts/schools are required to utilize the School Health Compliance Management System. If your district or school is not already enrolled, it will be required to subscribe to the platform. A $25 annual subscription fee will be billed directly by the neffy4Schools program to your school district.
Schools may purchase epinephrine delivery systems directly from a school health supplier or pharmacy. Schools will need a valid prescription or standing order for distribution from a licensed prescriber to purchase the medication.
Condition Specific Protocol
Condition specific protocols are required for nurses (RN and LPN) administering epinephrine delivery systems and a best practice recommendation for all school personnel. The condition specific protocol is an essential component of the over all emergency response plan developed to address life threatening allergic reactions.
148.235, Subd. (8) Prescription by Protocol allows RNs to implement a protocol that results in a prescription of legend (prescription) drugs for administration, including naloxone, based on conditions (as opposed to being based on specific patients).
Subd. (8). Prescription by Protocol states, “A registered nurse may implement a protocol that does not reference a specific patient and results in a prescription of a legend drug that has been predetermined and delegated by a licensed practitioner as defined under section 151.01, subdivision 23, when caring for a patient whose condition falls within the protocol and when the protocol specifies the circumstances under which the drug is to be prescribed or administered.”
MN Statute 121A.2207 Life-Threatening Allergies in Schools: Stock Supply of Epinephrine Delivery Systems
Subdivision 1. Districts and schools permitted to maintain supply states, “(b) Registered nurses may administer epinephrine delivery system in a school setting according to a condition-specific protocol as authorized under section 148.235, subdivision 8. Notwithstanding any limitation in sections 148.171 to 148.285, licensed practical nurses may administer epinephrine delivery systems in a school setting according to a condition-specific protocol that does not reference a specific patient and that specifies the circumstances under which the epinephrine delivery system is to be administered, when caring for a patient whose condition falls within the protocol.”
Therefore, the nurse (RN/LPN) working with a licensed prescriber must develop and follow a condition specific protocol for anaphylaxis. The Guidance for an Anaphylaxis Protocol in a School Setting further explains the nursing practice rationale behind the need for a condition specific protocol.
Templates for a condition specific protocol for both epinephrine auto-injector and neffy® have been developed.
Epinephrine auto-injector Condition Specific Protocol Template for the School Setting
neffy® Condition Specific Protocol Template for the School Setting
Schools choosing to use these templates must understand that the criteria in the template includes indications, contraindications, and side effects for administering epinephrine auto-injector. However, the criteria must be reviewed and further defined according to the licensed prescriber’s parameters who is authorizing by their signature. Additional criteria and prescribed actions may be necessary. The prescribed actions are examples and may not suit your school situation and may not include all possible actions. A licensed prescriber must review the criteria and actions and determine the appropriate action to be prescribed. It is recommended that the condition specific protocol be reviewed annually.
Many schools have a relationship with a licensed prescriber and have already maintain a supply of epinephrine and only need a condition specific protocol. These resources may help you connect with a provider to sign a condition specific protocol.