Sec. 10.13.04.03. 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.