Maryland Register

Issue Date:  February 1, 2019

Volume 46 • Issue 3 • Page 112-114

Title 10 
MARYLAND DEPARTMENT OF HEALTH

Subtitle 13 DRUGS

10.13.04 Emergency Use Auto-Injectable Epinephrine Program at Institutions of Higher Education

Authority: Health-General Article, §§2-104 and 13-7A-03, Annotated Code of Maryland

Notice of Proposed Action

[19-028-P]

The Secretary of Health proposes to adopt new Regulations .01—.03 under a new chapter, COMAR 10.13.04 Emergency Use Auto-Injectable Epinephrine Program at Institutions of Higher Education.

Statement of Purpose

The purpose of this action is to codify in regulations the Emergency Use Auto-Injectable Epinephrine Program at Institutions of Higher Education established in Health-General Article, §§13-7A-01—13-7A-09, Annotated Code of Maryland. These regulations will establish the policies and procedures for the administration of the program.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

The proposed action has no economic impact.

Economic Impact on Small Businesses

The proposed action has minimal or no economic impact on small businesses.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

.01 Scope.

This chapter applies to employees of food service facilities or recreation and wellness facilities on the premises of an institution of higher education as defined in Education Article, §10-101, Annotated Code of Maryland.

.02 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Affiliated individual” means an individual who is 18 years old or older who has been designated in writing by an eligible institution to serve either as a school health supervisor or as a certificate holder.

(2) “Agent” means an individual who:

(a) Is 18 years old or older;

(b) Has successfully completed, at the expense of the eligible institution, an emergency epinephrine educational training program approved by the Department; and

(c) Is designated in writing by a certificate holder to administer auto-injectable epinephrine in an emergency situation.

(3) “Anaphylaxis” means a sudden, severe, and potentially life–threatening allergic reaction that occurs when an individual is exposed to an allergen.

(4) “Applicant” means an individual applying for a Certificate for Emergency Epinephrine.

(5) “Auto-injectable epinephrine” means a portable, disposable drug delivery device that contains a premeasured single dose of epinephrine that is used to treat anaphylaxis in an emergency situation.

(6) “Certificate for emergency epinephrine” means a certificate issued by the Maryland Department of Health to an individual employed or designated by an eligible institution to obtain, store, and administer auto-injectable epinephrine.

(7) “Certificate holder” means an individual who is authorized by the Maryland Department of Health to obtain, store, and administer auto-injectable epinephrine to be used in an emergency situation.

(8) “Department” means the Maryland Department of Health.

(9) “Eligible institution” means an institution of higher education that has a food service facility or a recreation and wellness facility on the premises and that otherwise meets the requirements of this chapter.

(10) “Food service facility” has the meaning stated in COMAR 10.15.03.

(11) “School health supervisor” means an individual who:

(a) Provides health services for an institution of higher education; and

(b) Is licensed by the State as a:

(i) Physician;

(ii) Certified nurse practitioner; or

(iii) Registered nurse.

(12) “Successfully completed” means to pass a written examination with a grade of 75 percent or higher.

.03 Emergency Epinephrine.

A. An individual may apply, on a form prescribed by the Department, for a certificate for emergency epinephrine, which shall be valid for up to 1 year if the applicant:

(1) Is employed by a food service facility or a recreation and wellness facility at an eligible institution;

(2) Is 18 years old or older; and

(3) Has successfully completed, at the expense of the eligible institution, an emergency epinephrine educational training program approved by the Department.

B. The applicant shall submit to the Department with the form required in §A of this regulation a written policy that includes:

(1) Designation of agents and affiliated individuals;

(2) The name of the approved emergency epinephrine educational training program; and

(3) Procedures to:

(a) Store emergency auto-injectable epinephrine;

(b) Maintain the emergency auto-injectable epinephrine in a secure manner;

(c) Report use of emergency auto-injectable epinephrine according to §L of this regulation;

(d) Train an emergency epinephrine certificate holder and agent annually; and

(e) Maintain documentation of an emergency epinephrine certificate holder and agent training for 3 years.

C. A provider of an emergency epinephrine educational training program shall meet the requirements of COMAR 10.16.07.15C and D.

D. An individual teaching an emergency epinephrine educational training program shall be licensed as a physician, a registered nurse, or a certified nurse practitioner.

E. The Department shall:

(1) Issue a certificate for emergency epinephrine to an applicant who meets the requirements in §§A and B of this regulation;

(2) Deny the issuance of a certificate for emergency epinephrine to an applicant who does not meet the requirements in §§A and B of this regulation;

(3) Revoke or suspend the certificate for emergency epinephrine of an individual who does not meet the requirements in §§A and B of this regulation;

(4) Approve an emergency epinephrine educational training program if the training program meets the requirements of §C of this regulation;

(5) Disapprove an emergency epinephrine educational training program if the training program does not meet the requirement of §C of this regulation; and

(6) On or before January 31 of each year, publish a report summarizing the information obtained from the reported uses of emergency auto-injectable epinephrine at eligible institutions according to §L of this regulation.

F. A physician licensed to practice medicine in the State may prescribe auto-injectable epinephrine in the name of a certificate holder.

G. A pharmacist licensed to practice pharmacy in the State, or a physician, may dispense auto-injectable epinephrine under a prescription issued to a certificate holder.

H. A certificate holder may:

(1) On presentment of a certificate for emergency epinephrine, receive from any physician licensed to practice medicine in the State a prescription for auto-injectable epinephrine; and

(2) Possess and store prescribed auto-injectable epinephrine.

I. An eligible institution:

(1) Shall ensure that there is a written plan for the emergency epinephrine program that:

(a) Is approved annually, in writing, by a school health supervisor;

(b) Is on file at the eligible institution and is available for inspection; and

(c) Includes at a minimum:

(i) The name, title, and license number of the health supervisor;

(ii) Information on the emergency epinephrine educational training program used;

(iii) Procedures for disseminating information to staff on the emergency epinephrine program;

(iv) Procedures for the proper storage and handling of medication;

(v) Procedures for the use of emergency services and 911 services; and

(vi) Procedures for documenting incidents involving the administration of auto-injectable epinephrine by a certificate holder in accordance with §L of this regulation;

(2) Shall ensure that a certificate holder who is employed by, or a designated affiliated individual of, the institution complies with all provisions of this chapter;

(3) Shall provide the Department with access to records and documents required under this chapter;

(4) Shall designate in writing the certificate holders who will be responsible for the storage, maintenance, and control of the supply of auto-injectable epinephrine;

(5) May not obtain or store auto-injectable epinephrine unless the eligible institution has at least two certificate holders; and

(6) Shall maintain a copy of the certificate issued to a certificate holder under §E of this regulation for at least 3 years.

J. Certificate Holders.

(1) Subject to §I(4) of this regulation, a certificate holder may obtain:

(a) A prescription for a supply of auto-injectable epinephrine from a licensed physician as provided in §F of this regulation; and

(b) A supply of auto-injectable epinephrine from a licensed pharmacist or a licensed physician as provided in §G of this regulation.

(2) A certificate holder shall store a supply of auto-injectable epinephrine obtained under §J(1) of this regulation:

(a) In accordance with the manufacturer’s instructions; and

(b) In a location that is readily accessible to certificate holders and agents in an emergency situation.

K. In an emergency situation when physician or emergency medical services are not immediately available, a certificate holder or agent may administer auto-injectable epinephrine to an individual who is experiencing or believed in good faith by the certificate holder or agent to be experiencing anaphylaxis.

L. An eligible institution shall ensure that an incident that occurred on the premises of a food service facility or recreation and wellness facility at an eligible institution that involved the administration of auto-injectable epinephrine by a certificate holder or agent is reported:

(1) Immediately to the school health supervisor and, in the case of a minor, to the minor’s parent or guardian; and

(2) To the Department within 5 business days of the incident on a form prescribed by the Department.

ROBERT R. NEALL
Secretary of Health

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