Epinephrine Auto-injector Law

Epinephrine Auto-injector Law

State law now allows recreation camps, colleges, universities, preschools, and daycares to obtain and use epinephrine auto-injectors without a prescription with specific training.

Anaphylaxis is a severe allergic reaction that can be life-threatening. When a person is experiencing anaphylaxis, one potentially helpful response is to deliver a medicine called epinephrine. This is typically done using a tool called an epinephrine auto-injector. Starting July 1, 2015, recreation camps, colleges, universities, preschools and daycares are allowed to obtain epinephrine auto-injectors without a prescription so that they can have the device on hand for use in emergencies when an owner, manager, employee or agent of the entity believes, in good faith, that an individual is experiencing anaphylaxis. This is not a mandate and an organization can choose to provide the epinephrine auto injectors or not. See Minnesota 2015 Session Laws, Chapter 71, Article 8, Section 34. The language is also available below.

What are “recreation camps”? What are “colleges” and “universities”? What are “daycares” and “preschools”?

Minnesota laws governing recreation camps are in Minn. Stat. secs. 327.14 to 327.28. Minnesota laws governing colleges and universities are in Minn. Stat. secs. 136A.62 and 136A.821. “Daycares” and “preschools” include both licensed and license-exempt programs that provide daycare or preschool services to children. Minnesota laws governing licensed child care programs are in Minnesota Statutes, Chapter 245A; Minnesota Rules, Chapter 9502 (family child care); and, Minnesota Rules, Chapter 9503 (child care centers).

If your authorized entity is licensed, you must still abide by all licensing requirements. If you have questions about how this new law impacts your compliance with licensing requirements, please contact your licensing agency.

Who must get the training?

Organizations choosing to obtain epinephrine auto-injectors without a prescription must designate employees or agents to obtain the training and who then are authorized to provide the device to the individual, a caregiver, or legal guardian; or to administer the injector to the individual directly when symptoms of anaphylaxis exist. There is no limit to the numbers of employees or agents who can obtain the training and be responsible for providing or administering the injectors. However, under the law, each designated employee is also responsible for the storage, maintenance and control of the epinephrine auto-injectors too. The training must occur every two years.

What is the required training?

Training can be conducted online or in person and must cover the following topics:

  1. How to recognize the signs and symptoms of severe allergic reactions, including anaphylaxis.
  2. Standards and procedures for the storage and administration of an epinephrine auto-injector.
  3. Emergency follow-up procedures.

As long as the training teaches about the above topics, there are no required numbers of training hours to meet.

Who are the trainers?

Training must be provided by one of the following:

  1. A nationally recognized organization experienced in training laypersons in emergency health treatment.
  2. A statewide organization with experience providing training on allergies and anaphylaxis under the supervision of board-certified allergy medical advisors.
  3. An entity or individual approved by the commissioner of health to provide an anaphylaxis training program.

There are two training organizations to date:

The training organization will provide a certificate of completion to each participant. There is no required form for the training certificate, but each certificate should contain at least the following information: 

  1. Name of the trainer or training organization.
  2. Date training completed.
  3. The topics covered in the training.

Where do we get the epinephrine auto-injectors?

The injectors are available from pharmacies licensed by the Minnesota Board of Pharmacy (Board) as wholesale drug distributors pursuant to Minn. Stat. section 151.47. Not all pharmacies are licensed as wholesalers. You can use the Board’s Licensee / Registrant Search to find pharmacies that are licensed as wholesalers. You can also call your local community or hospital pharmacy to inquire if they are licensed as wholesaler. Note that an organization must present a valid training certificate to the pharmacy/wholesaler in order to purchase epinephrine auto-injectors.

How do we store the epinephrine auto-injectors?

An organization shall store the epinephrine auto-injectors in a location readily accessible in an emergency and in accordance with the device’s instructions. An authorized entity shall designate employees or agents who have completed required training to be responsible for the storage, maintenance, and control of epinephrine auto-injectors obtain and possessed by the authorized entity.

Are there protections for organizations or individuals who administer epinephrine auto-injectors?

Authorized entities, designated agents or employees of the authorize entities, trainers and pharmacies or manufacturers that dispense epinephrine auto-injectors in good faith, and are in compliance with the regulation, are protected under the Minnesota Good Samaritan statutory language under section 604A.01.

Do entities or organizations need to get on a list in order to possess the epinephrine auto-injectors?

No. Neither the Commissioner of Health nor other state agencies are keeping a list of organizations choosing to obtain epinephrine auto-injectors. If your organization is one of the entity types listed above, you can designate persons, get them trained, submit the training certificates to an authorized wholesale pharmacy and obtain the epinephrine auto-injectors.

I belong to an organization that is not listed in the entity types above. Is there any way for other types of organizations to be added to the list of entity types so that we can also obtain epinephrine auto-injectors?

The law states that after July 1, 2016, the Commissioner of Health may add additional authorized entity categories for legislators’ consideration during the 2017 legislative session. After July 1, 2016, please direct your request to Division Director’s Office, Health Regulation Division, Minnesota Department of Health, P.O. Box 64900, St. Paul, MN, 55164-0900. In the meantime, if you have questions, please email Susan Winkelmann, Assistant Division Director, Health Regulation Division at susan.winkelmann@state.mn.us.

Minnesota 2015 Session Laws, Chapter 71, Article 8, Section 34
Sec. 34. [144.999] Life-Saving Allergy Medication

Subdivision 1. Definitions.

(a) For purposes of this section, the following terms have the meanings given.
(b) "Administer" means the direct application of an epinephrine auto-injector to the body of an individual.
(c) "Authorized entity" means entities that fall in the categories of recreation camps, colleges and universities, preschools and daycares, and any other category of entities or organizations that the commissioner authorizes to obtain and administer epinephrine auto-injectors without a prescription. This definition does not include a school covered under section 121A.2207.
(d) "Commissioner" means the commissioner of health.
(e) "Epinephrine auto-injector" means a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body.
(f) "Provide" means to supply one or more epinephrine auto-injectors to an individual or the individual's parent, legal guardian, or caretaker.

Subd. 2. Commissioner duties.

The commissioner may identify additional categories of entities or organizations to be authorized entities if the commissioner determines that individuals may come in contact with allergens capable of causing anaphylaxis. Beginning July 1, 2016, the commissioner may annually review the categories of authorized entities and may authorize additional categories of authorized entities as the commissioner deems appropriate. The commissioner may contract with a vendor to perform the review and identification of authorized entities.

Subd. 3. Obtaining and storing epinephrine auto-injectors.

(a) Notwithstanding section 151.37, an authorized entity may obtain and possess epinephrine auto-injectors to be provided or administered to an individual if, in good faith, an owner, manager, employee, or agent of an authorized entity believes that the individual is experiencing anaphylaxis regardless of whether the individual has a prescription for an epinephrine auto-injector. The administration of an epinephrine auto-injector in accordance with this section is not the practice of medicine.
(b) An authorized entity may obtain epinephrine auto-injectors from pharmacies licensed as wholesale drug distributors pursuant to section 151.47. Prior to obtaining an epinephrine auto-injector, an owner, manager, or authorized agent of the entity must present to the pharmacy a valid certificate of training obtained pursuant to subdivision 5.
(c) An authorized entity shall store epinephrine auto-injectors in a location readily accessible in an emergency and in accordance with the epinephrine auto-injector's instructions for use and any additional requirements that may be established by the commissioner. An authorized entity shall designate employees or agents who have completed the training program required under subdivision 5 to be responsible for the storage, maintenance, and control of epinephrine auto-injectors obtained and possessed by the authorized entity.

Subd. 4. Use of epinephrine auto-injectors.

(a) An owner, manager, employee, or agent of an authorized entity who has completed the raining required under subdivision 5 may:
(1) provide an epinephrine auto-injector for immediate administration to an individual or the individual's parent, legal guardian, or caregiver if the owner, manager, employee, or agent believes, in good faith, the individual is experiencing anaphylaxis, regardless of whether the individual has a prescription for an epinephrine auto-injector or has previously been diagnosed with an allergy; or
(2) administer an epinephrine auto-injector to an individual who the owner, manager, employee, or agent believes, in good faith, is experiencing anaphylaxis, regardless of whether the individual has a prescription for an epinephrine auto-injector or has previously been diagnosed with an allergy.
(b) Nothing in this section shall be construed to require any authorized entity to maintain a stock of epinephrine auto-injectors.

Subd. 5. Training.

(a) In order to use an epinephrine auto-injector as authorized under subdivision 4, an individual must complete, every two years, an anaphylaxis training program conducted by a nationally recognized organization experienced in training laypersons in emergency health treatment, a statewide organization with experience providing training on allergies and anaphylaxis under the supervision of board-certified allergy medical advisors, or an entity or individual approved by the commissioner to provide an anaphylaxis training program. The commissioner may approve specific entities or individuals to conduct the training program or may approve categories of entities or individuals to conduct the training program. Training may be conducted online or in person and, at a minimum, must cover:
(1) how to recognize signs and symptoms of severe allergic reactions, including anaphylaxis;
(2) standards and procedures for the storage and administration of an epinephrine auto-injector; and
(3) emergency follow-up procedures.
(b) The entity or individual conducting the training shall issue a certificate to each person who successfully completes the anaphylaxis training program. The commissioner may develop, approve, and disseminate a standard certificate of completion. The certificate of completion shall be valid for two years from the date issued.

Subd. 6. Good samaritan protections.

Any act or omission taken pursuant to this section by an authorized entity that possesses and makes available epinephrine auto-injectors and its employees or agents, a pharmacy or manufacturer that dispenses epinephrine auto-injectors to an authorized entity, or an individual or entity that conducts the training described in subdivision 5 is considered "emergency care, advice, or assistance" under section 604A.01.

Updated Wednesday, July 13, 2016 at 02:49PM