AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO THE APPLICATION OF NASAL EPINEPHRINE.

Legislation Document

SPONSOR:

Rep. Neal & Sen. Sokola

Rep. K. Johnson

HOUSE OF REPRESENTATIVES

153rd GENERAL ASSEMBLY

HOUSE BILL NO. 466

AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO THE APPLICATION OF NASAL EPINEPHRINE.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:

Section 1. Amend Subchapter II, Chapter 30E, Title 16 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows:

Subchapter II. Access to Epinephrine Autoinjectors

and Intranasal Epinephrine Sprays

in Institutions of Higher Education

§ 3011E. Definitions.

For purposes of this subchapter:

(1) “Administer” means the direct application of an epinephrine autoinjector

or intranasal epinephrine spray

to the body of an individual.

(2) “Dispensing” means providing 1 or more epinephrine autoinjectors

or intranasal epinephrine sprays

according to an order of a licensed health-care provider.

(3) “Epinephrine autoinjector” means a single-use device used for the automatic injection of a premeasured dose of epinephrine into the human body.

(4) “Institution of higher education” means a public or private educational institution, physically located in this State, that provides a program of education beyond the high school level and awards an associate’s, bachelor’s, or advanced degree.

(5) “Licensed health-care provider” means a physician or an individual licensed and authorized to write prescriptions for individuals under Title 24.

(6) “Records’' means the recordings of interviews and all oral or written reports, statements, minutes, memoranda, charts, statistics, data, and other documentation generated by

the State Emergency Medical Services Medical Director

any administration or review of epinephrine autoinjectors.

(7) “Self-administration” means the process whereby an individual gives themselves a single dose of epinephrine from a previously dispensed, properly labeled autoinjector

or intranasal epinephrine spray

.

(8) “Intranasal epinephrine spray” means a single-dose nasal spray that delivers epinephrine through the nostrils.

§ 3012E. Emergency access to epinephrine autoinjectors

and Intranasal epinephrine sprays

.

The Department shall do all of the following:

(1) Promote the safe use of epinephrine autoinjectors

and intranasal epinephrine sprays

at institutions of higher education to reduce deaths from anaphylaxis.

(2) Promulgate regulations to implement this subchapter.

§ 3013E. Epinephrine

autoinjectors;

autoinjectors and intranasal epinephrine sprays;

prescribing, dispensing, storage.

(a) A licensed health-care provider may prescribe epinephrine autoinjectors

and intranasal epinephrine sprays

in the name of an institution of higher education for use under this subchapter.

(b) A licensed health-care provider or pharmacist may dispense epinephrine autoinjectors

and intranasal epinephrine sprays

under a prescription issued in the name of an institution of higher education.

(c) An institution of higher education may acquire and stock a supply of epinephrine autoinjectors

and intranasal epinephrine sprays

under a prescription issued under this subchapter as follows:

(1) The epinephrine autoinjectors

and intranasal epinephrine sprays

must be stored in a location readily accessible in an emergency.

(2) The epinephrine autoinjectors

and intranasal epinephrine sprays

must be stored in accordance with the

epinephrine autoinjector’s

instructions for use and any additional requirements established by the Department.

(3) An institution of higher education shall designate employees or agents who have completed the training required under § 3015E of this title to be responsible for the storage, maintenance, and general oversight of epinephrine autoinjectors

and intranasal epinephrine sprays

acquired by the institution of higher education.

§ 3014E. Epinephrine

autoinjectors;

autoinjectors and intranasal epinephrine sprays

administration.

(a) An employee or agent of an institution of higher education, who has completed the training required under § 3015E of this title may, on the premises of or in connection with the institution of higher education, use epinephrine autoinjectors

or intranasal epinephrine sprays

prescribed under § 3013E of this title as follows:

(1) Provide an epinephrine autoinjector

or intranasal epinephrine spray

to an individual who the employee, agent, or the individual believes in good faith is experiencing anaphylaxis for immediate self-administration, regardless of whether the individual has a prescription for an epinephrine autoinjector

or intranasal epinephrine spray

or has previously been diagnosed with an allergy.

(2) Administer an epinephrine autoinjector

or intranasal epinephrine spray

to any individual who the employee or agent believes in good faith is experiencing anaphylaxis, regardless of whether the individual has a prescription for an epinephrine autoinjector

or intranasal epinephrine spray

or has previously been diagnosed with an allergy.

(b) An individual who uses an epinephrine autoinjector

or intranasal epinephrine spray

under subsection (a) of this section must do all of the following:

(1) Notify the appropriate emergency medical service units as soon as possible.

(2) Report the use to the appropriate licensed physician or medical authority, if known.

§ 3015E. Epinephrine

autoinjectors;

autoinjectors and intranasal epinephrine sprays

training.

(a) An employee or agent of an institution of higher education must complete an anaphylaxis training program before providing or administering an epinephrine autoinjector

or intranasal epinephrine spray

made available by an institution of higher education. The training must be conducted by a nationally-recognized organization experienced in training laypersons in emergency health treatment or an entity or individual approved by the Department. Training may be conducted online or in person and, at a minimum, must cover all of the following:

(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

autoinjector.

autoinjector

and intranasal epinephrine spray

.

(3) Risks of administering an epinephrine autoinjector

or intranasal epinephrine spray

that has expired or that was not stored at the proper temperature.

(4) Potential contraindications, risks, side effects, or medication reactions after appropriate use.

(5) The differences in usage, storage, and administration of

an

EpiPen Jr.

autoinjectors

autoinjectors and intranasal epinephrine sprays

.

(6) What to do if an individual is at a borderline weight.

(7) Emergency follow-up procedures.

(b) The entity that conducts the training shall issue a certificate, on a form developed or approved by the Department, to each person who successfully completes the anaphylaxis training program.

(c) An individual who successfully completes an anaphylaxis training under this section may use epinephrine autoinjectors

and intranasal epinephrine sprays

prescribed under § 3013E of this title for 2 years from the date of completion on the certificate issued under subsection (b) of this section.

§ 3016E. Epinephrine

autoinjectors;

autoinjector and intranasal epinephrine spray

immunity.

(a) A licensed health-care provider who prescribes or dispenses an epinephrine autoinjector

or intranasal epinephrine spray

to an institution of higher education under this subchapter must do so in good faith and with reasonable care. Unless it is established that the licensed health-care provider caused injuries or death as a result of unreasonable care, wilfully, wantonly, or by gross negligence, a licensed health-care provider is not subject to any of the following as a result of prescribing or dispensing an epinephrine autoinjector

or intranasal epinephrine spray

under this subchapter:

(1) Disciplinary or other adverse action under the professional licensing laws of this State.

(2) Criminal liability.

(3) Liability for damages for injuries or death.

(b) A pharmacist who dispenses an epinephrine autoinjector or

intranasal epinephrine spray

to an institution of higher education under this subchapter must do so in good faith and with reasonable care. Unless it is established that the pharmacist caused injuries or death as a result of unreasonable care, wilfully, wantonly, or by gross negligence, a pharmacist is not subject to any of the following as a result of dispensing an epinephrine autoinjector

or intranasal epinephrine spray

under this subchapter:

(1) Disciplinary or other adverse action under the professional licensing laws of this State.

(2) Criminal liability.

(3) Liability for damages for injuries or death.

(c) An institution of higher education that possesses and makes available epinephrine autoinjector

or intranasal epinephrine spray

under this subchapter must do so in good faith and with reasonable care. Unless it is established that the institution of higher education caused injuries or death as a result of unreasonable care, wilfully, wantonly, or by gross negligence, an institution of higher education is not subject to any of the following as a result of possessing or making available an epinephrine autoinjector

or intranasal epinephrine spray

under this subchapter:

(1) Disciplinary or other adverse action under the professional licensing laws of this State.

(2) Criminal liability.

(3) Liability for damages for injuries or death.

(d) An individual who administers or provides an epinephrine autoinjector

or intranasal epinephrine spray

under this subchapter is exempt from liability under § 6801 of this title.

§ 3017E. Epinephrine

autoinjectors;

autoinjectors and intranasal epinephrine sprays

reports.

(a) An institution of higher education that possesses and makes available epinephrine autoinjectors

or intranasal epinephrine spray

shall

must

submit to the Department, on a form developed by the Department, a report of each incident that involves the administration of the institution of higher education’s epinephrine autoinjector

or intranasal epinephrine spray

.

(b) Records

of the State Emergency Medical Services Medical Director, and emergency medical services quality care review committee

relating to epinephrine autoinjector

or intranasal epinephrine spray

reviews and audits are confidential and privileged, protected, and are not subject to discovery, subpoena, or admission into evidence in any judicial or administrative proceeding. Raw data used in any epinephrine autoinjector

or intranasal epinephrine spray

review or audit is not a public record under Chapter 100 of Title 29 and is confidential under § 1768(b) of Title 24.

(c) The Department shall file an annual report with the General Assembly by January 1 that provides all of the following information for the prior academic year:

(1) A summary and analysis of all reports submitted under subsection (a) of this section.

(2) The number of institutions of higher education that received epinephrine autoinjectors under this subchapter.

(3) The number of individuals trained to administer epinephrine autoinjectors under this subchapter.

[Repealed].

SYNOPSIS

This Act adds authority and guidelines for access to and use of intranasal epinephrine nasal sprays at institutions of higher education to the existing framework for access to and use of epinephrine injectors. This Act also removes the requirement of the Department of Public Health from filing an annual report regarding the use of epinephrine autoinjectors for the prior academic year with the General Assembly under this section.