Stock Emergency-Use Epinephrine Guidelines for Colorado Schools

Anaphylaxis is a severe, rapidly progressing allergic reaction that may become life-threatening within minutes. Prompt administration of epinephrine is the first-line treatment and can be lifesaving.

Colorado law permits schools to adopt policies allowing them to stock emergency-use epinephrine for administration to any student believed in good faith to be experiencing anaphylaxis, regardless of whether the student has a prescription for epinephrine.

A local governing authority may adopt a policy authorizing schools under its jurisdiction to acquire, maintain, and administer stock emergency-use epinephrine for use in an anaphylactic emergency.

If a local governing authority adopts such a policy, it should include procedures consistent with C.R.S. 22-1-119.5 and the Rules for the Administration of Medications (1 CCR 301-68). At a minimum, the policy should address:

• Authorization to acquire, maintain, and administer stock emergency-use epinephrine.
• Designation and training of school personnel authorized to administer stock emergency-use epinephrine.
• Standing orders and clinical protocols issued by a Colorado physician, physician assistant, or advanced practice registered nurse with prescriptive authority.
• Procurement, storage, inspection, replacement, and disposal of stock emergency-use epinephrine.
• Procedures for responding to suspected anaphylaxis, including administration of emergency-use epinephrine to any student believed in good faith to be experiencing anaphylaxis, regardless of whether the student has a prescription for emergency-use epinephrine.
• Activation of emergency medical services (911), parent or guardian notification, documentation, and required reporting following administration of emergency-use epinephrine.

Schools maintaining stock emergency-use epinephrine must operate under current standing orders and clinical protocols issued by a Colorado physician, physician assistant, or advanced practice registered nurse with prescriptive authority, in accordance with C.R.S. 22-1-119.5 and 1 CCR 301-68.

Standing orders and clinical protocols should specify:

• Authorized prescriber information.
• School(s) or local education provider covered by the standing order.
• Effective and expiration dates.
• FDA-approved emergency-use epinephrine product(s) authorized, including route of administration, dosage or strength, and product-specific administration instructions.
• Indications for administration.
• Authorized personnel.
• Emergency response procedures.
• Instructions regarding repeat dosing, if authorized.
• Documentation and reporting requirements.
• Storage and replacement instructions, as appropriate.

A sample standing order is provided in Appendix A to assist local education providers and authorized prescribers in developing standing orders that meet local needs and comply with current Colorado law and regulations.

In accordance with C.R.S. 22-1-119.5, a local governing authority that adopts a policy to maintain stock emergency-use epinephrine shall identify appropriate staff to receive emergency anaphylaxis treatment training and authorize designated personnel to administer stock emergency-use epinephrine.

For purposes of stock emergency-use epinephrine, appropriate staff means employees of the school whom the principal or equivalent executive, in consultation with the school nurse, determines to be appropriate recipients of emergency anaphylaxis treatment training.

Designated personnel may administer stock emergency-use epinephrine when:

• They have completed the required training in accordance with 1 CCR 301-68; and
• They believe in good faith that a student is experiencing anaphylaxis, regardless of whether the student has a prescription for emergency-use epinephrine.

Schools are encouraged to designate sufficient trained personnel to ensure an appropriate response to anaphylactic emergencies during the school day and school-sponsored activities.

Who Must Complete Training

Individuals designated to administer stock emergency-use epinephrine must complete a state-approved emergency anaphylaxis treatment training program in accordance with the Rules for the Administration of Medications (1 CCR 301-68) and local policy.

The local education provider shall ensure that appropriate staff receive emergency anaphylaxis treatment training. Appropriate staff are employees of the school whom the principal or equivalent executive, in consultation with the school nurse, determines to be appropriate recipients of the training. Appropriate staff include, but are not limited to, employees who are directly involved during the school day with a student who has a known food allergy. (C.R.S. 22-2-135(2) and (3)(a)(III); 1 CCR 301-68, Rule 3)

Required Training Content

Training shall include the content required by Rule 3.00 of the Rules for the Administration of Medications (1 CCR 301-68). Training of Designated School Personnel must be conducted by a School Nurse or Healthcare Practitioner using a state approved course and is encouraged to be completed annually.

Training for designated school personnel must include, at a minimum:

• A basic understanding of food allergies and the importance of reasonable avoidance of agents that may cause anaphylaxis.
• Recognition of the signs and symptoms of anaphylaxis.
• Appropriate response to anaphylaxis, including the correct administration of emergency-use epinephrine.
• Standards and procedures for the storage of emergency-use epinephrine.
• Emergency follow-up procedures after administering emergency-use epinephrine.
• Awareness of a student's ability to carry and self-administer emergency-use epinephrine, when authorized.
• The purpose of individualized health care plans and allergy action plans for students with known life-threatening allergies.
• Documentation and reporting requirements related to severe allergic reactions and the administration of emergency-use epinephrine.

The local education provider is responsible for ensuring that designated personnel complete a state-approved emergency anaphylaxis treatment training program before administering stock emergency-use epinephrine.

Schools should maintain documentation of completed training in accordance with local policy.

State-Approved Training Resources

The Colorado Department of Education maintains a list of approved training programs for designated school personnel on the School Nursing & Health Training Tools – Food Allergy Training webpage. Local education providers should ensure designated personnel complete one of the currently approved training programs available on that webpage.

Note: State-approved emergency anaphylaxis treatment training programs may differ in the topics they address. Local education providers are responsible for ensuring designated personnel receive instruction on all training requirements outlined in the Rules for the Administration of Medications (1 CCR 301-68) and any additional topics required by local policy.

Schools that adopt a policy to maintain stock emergency-use epinephrine may acquire and maintain a supply of FDA-approved emergency-use epinephrine in accordance with C.R.S. 22-1-119.5.

A local governing authority may enter into arrangements with manufacturers or third-party suppliers to obtain emergency-use epinephrine at fair-market price, reduced cost, or no cost.

Schools should establish local procedures for the procurement, inventory management, replacement, and disposal of stock emergency-use epinephrine in accordance with local policy.

Stock emergency-use epinephrine shall be stored in accordance with the Rules and Regulations Governing Schools (6 CCR 1010-6), the Rules for the Administration of Medications (1 CCR 301-68), and the manufacturer's instructions for use. Emergency-use epinephrine must be:

• Inaccessible to students.
• Stored in the original manufacturer's container.
• Stored in a controlled area separated from food, cleaning compounds, and other toxic substances.
• Immediately available to trained school personnel and in an unlocked location (e.g., emergency kit or bag, cabinet).

Medications acquired by the school shall be disposed of in accordance with applicable state requirements. Additional guidance on medication disposal is available in the Medication Guidelines for Colorado School and Child Care Settings.

When a trained designated school employee or licensed school nurse believes in good faith that a student is experiencing anaphylaxis, emergency-use epinephrine may be administered in accordance with the local education provider's policy, the standing order, C.R.S. 22-1-119.5, and the Rules for the Administration of Medications (1 CCR 301-68).

When emergency-use epinephrine is administered, the following actions are required:

• Activate emergency medical services (911) immediately.
• Implement appropriate post-administration procedures.
• Notify the student's parent or guardian in accordance with local policy.
• Complete required documentation and reporting in accordance with local policy and the Rules for the Administration of Medications (1 CCR 301-68), including required reporting to the Colorado Department of Education, discussed below.

Documentation

Schools should document each administration of stock emergency-use epinephrine in accordance with local policy and maintain records of:

• Date and time of the incident.
• Student involved.
• Signs and symptoms observed.
• Medication administered, including dose and route.
• Individual administering the medication.
• Activation of emergency medical services (911).
• Parent or guardian notification.
• Outcome of the incident.

Required Reporting to the Colorado Department of Education

Colorado law and the Rules for the Administration of Medications (1 CCR 301-68) require schools to submit reports to the Colorado Department of Education following the administration of emergency-use epinephrine and to report designated personnel authorized to administer stock emergency-use epinephrine.

Annual Report of Designated Personnel Authorized to Administer Stock Emergency-Use Epinephrine

Local education providers that authorize schools to maintain stock emergency-use epinephrine must annually report the designated personnel authorized to administer stock emergency-use epinephrine, as required by C.R.S. 22-1-119.5 and 1 CCR 301-68.

Severe Allergic Reaction and/or Emergency-Use Epinephrine Administration Report

In accordance with 1 CCR 301-68, Section 6.00, all public schools, and nonpublic schools that maintain a supply of stock emergency-use epinephrine, must submit the required Severe Allergic Reaction and/or Emergency-Use Epinephrine Administration Report to the Colorado Department of Education within 10 days of an incident involving:

• A severe allergic reaction;
• The administration of emergency-use epinephrine; or
• Both.

Current reporting forms, instructions, and submission information are available on the Colorado Department of Education School Nursing & Health Home Page – Data Reporting webpage.

C.R.S. 22-1-119.5 includes liability provisions related to stock emergency-use epinephrine. Local education providers should refer to the statute for the complete liability provisions. 

Questions regarding liability should be directed to legal counsel.

Colorado Department of Education

• Medication Guidelines for Colorado School and Child Care Settings
• School Nursing & Health Training Tools (state-approved emergency anaphylaxis treatment training options under "Food Allergy Trainings")
• Required Reports:
  • Severe Allergic Reaction and/or Emergency-Use Epinephrine Administration Report
  • Annual Report of Designated Personnel Authorized to Administer Stock Emergency-Use Epinephrine

Colorado Laws and Rules

• C.R.S. 22-1-119.5 – Asthma, Food Allergy, and Anaphylaxis Health Management
• C.R.S. 22-1-119.3 – Student Possession and Administration of Prescription Medication
• C.R.S. 22-2-135 – Food Allergy and Anaphylaxis Management
• 1 CCR 301-68 – Rules for the Administration of Medications
• 6 CCR 1010-6 – Rules and Regulations Governing Schools
• C.R.S. Title 12, Article 255 – Nurse and Nurse Aide Practice Act
• 3 CCR 716-1 – Board of Nursing Rules and Regulations

This Sample Standing Order for Stock Emergency-Use Epinephrine may be used by local education providers when developing or updating a standing order for stock emergency-use epinephrine. It should be reviewed and adapted in collaboration with an authorized prescriber and legal counsel to reflect the emergency-use epinephrine product(s) authorized for use. 

Notes:  

• Depending on pharmacy requirements and the product(s) authorized, the prescriber may also need to provide one or more prescriptions to enable the local education provider to obtain the medication.
• This sample standing order is provided in Word format so the LEP can edit to reflect their individual policy, and the LEP would need to make the final product an accessible fillable form.

Children's Hospital Colorado has also developed the Colorado Allergy Care Plan Visuals, which provide product-specific administration instructions and illustrations for currently available emergency-use epinephrine devices. This resource may be used to support training and review of the authorized emergency-use epinephrine product(s) identified in the standing order.