2014 -- H 7576 SUBSTITUTE A

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LC004745/SUB A

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2014

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A N   A C T

RELATING TO HEALTH AND SAFETY - EPINEPHRINE

     Introduced By: Representatives Serpa, and Fellela

     Date Introduced: February 26, 2014

     Referred To: House Health, Education & Welfare

     It is enacted by the General Assembly as follows:

     SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby

amended by adding thereto the following chapter:

CHAPTER 6.4

LIFE-SAVING ALLERGY MEDICATION - STOCK SUPPLY OF EPINEPRHINE AUTO-

INJECTORS - EMERGENCY ADMINISTRATION

     23-6.4-1. Definitions. -- As used in this chapter:

     (1) “Administer” means the direct application of an epinephrine auto-injector to the body

of an individual.

     (2) “Authorized entity” means any entity or organization at, or in connection with, where

allergens capable of causing anaphylaxis may be present, as identified by the department of

health. The department shall, through rule or other guidance, identify the types of entities and

organizations that are considered authorized entities no later than January 1, 2015, and shall

review and update such rule or guidance at least annually thereafter.

     (3) “Authorized health care provider” means a physician, nurse, or other person duly

authorized by law, in the state in which they practice, to prescribe drugs.

     (4) “Epinephrine auto-injector” means a single-use device used for the automatic

injection of a premeasured dose of epinephrine into the human body.

     (5) “Provide” means the supplying of one or more epinephrine auto-injectors to an

individual.

     (6) “Self-administration” means a person’s discretionary use of an epinephrine auto-

injector.

     23-6.4-2. Prescribing to an authorized entity permitted. – An authorized health care

provider may prescribe epinephrine auto-injectors in the name of an authorized entity for use in

accordance with this section, and pharmacists may dispense epinephrine auto-injectors pursuant

to a prescription issued in the name of an authorized entity.

      23-6.4-3. Designated entities permitted to maintain supply. – An authorized entity

may acquire and stock a supply of epinephrine auto-injectors pursuant to a prescription issued in

accordance with this chapter. Such epinephrine auto-injectors shall be stored 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 department of health. An

authorized entity shall designate employees or agents who have completed the training required

by § 23-6.5-6 to be responsible for the storage, maintenance, and general oversight of epinephrine

auto-injectors acquired by the authorized entity.

     23-6.4-4. Use of epinephrine auto-injectors. – An employee or agent of an authorized

entity, or other individual, who has completed the training required by § 23-6.5-6, may, on the

premises of or in connection with the authorized entity, use epinephrine auto-injectors prescribed

pursuant to § 23-6.4-2 to:

     (1) Provide an epinephrine auto-injector to any individual who, the employee, agent, or

other individual, believes in good faith is experiencing anaphylaxis, for immediate self-

administration, regardless of whether the individual has a prescription for an epinephrine auto-

injector or has previously been diagnosed with an allergy.

     (2) Administer an epinephrine auto-injector to any individual who, the employee, agent,

or other individual, 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.

     23-6.4-5. Expanded availability. – An authorized entity that acquires a stock supply of

epinephrine auto-injectors pursuant to a prescription issued in accordance with this chapter, may

make such epinephrine auto-injectors available to individuals other than those trained individuals

described in § 23-6.5-4, and such individuals may administer such epinephrine auto-injector to

any individual believed in good faith to be experiencing anaphylaxis, if the epinephrine auto-

injectors are stored in a locked, secure container and are made available only upon remote

authorization by an authorized health care provider after consultation with the authorized health

care provider by audio, televideo, or other similar means of electronic communication.

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Consultation with an authorized health care provider for this purpose shall not be considered the

practice of telemedicine or otherwise be construed as violating any law or rule regulating the

authorized health care provider’s professional practice.

     23-6.4-6. Training. – An employee, agent, or other individual described in § 23-6.5-4

must complete an anaphylaxis training program prior to providing or administering an

epinephrine auto-injector made available by an authorized entity. Such training shall be

conducted by a nationally recognized organization experienced in training laypersons in

emergency health treatment, or an entity or individual approved by the department of health.

Training may be conducted online or in person and, at a minimum, shall cover:

     (1) Techniques on how to recognize 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.

     The entity that conducts the training shall issue a certificate, on a form developed or

approved by the department of health, to each person who successfully completes the anaphylaxis

training program.

     23-6.4-7. Good Samaritan protections. – An authorized entity that possesses and makes

available epinephrine auto-injectors and its employees, agents, and other trained individuals; a

person who uses an epinephrine auto-injector made available pursuant to § 23-6.5-5; an

authorized health care provider who prescribes epinephrine auto-injectors to an authorized entity;

and an individual or entity that conducts the training described in § 23-6.5-6, shall not be liable

for any civil damages that result from the administration or self-administration of an epinephrine

auto-injector; the failure to administer an epinephrine auto-injector; or any other act or omission

taken pursuant to this chapter; provided, however, this immunity does not apply to acts or

omissions constituting gross negligence or willful or wanton conduct. The administration of an

epinephrine auto-injector in accordance with this chapter is not the practice of medicine. This

section does not eliminate, limit, or reduce any other immunity or defense that may be available

under state law. An entity located in this state shall not be liable for any injuries or related

damages that result from the provision or administration of an epinephrine auto-injector by its

employees or agents outside of this state if the entity or its employee or agent:

     (1) Would not have been liable for such injuries or related damages had the provision or

administration occurred within this state; or

     (2) Are not liable for such injuries or related damages under the law of the state in which

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such provision or administration occurred.

     23-6.4-8. Reporting. – An authorized entity that possesses and makes available

epinephrine auto-injectors shall submit to the department of health, on a form developed by the

department of health, a report of each incident on the authorized entity’s premises that involves

the administration of an epinephrine auto-injector. The department of health shall annually

publish a report that summarizes and analyzes all reports submitted to it under this section.

     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO HEALTH AND SAFETY - EPINEPHRINE

***

     This act would regulate the use and acquisition of epinephrine auto-injectors to treat

allergic reactions.

     This act would take effect upon passage.

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