Current through Register Vol. 51, No. 19, September 20, 2024
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 participating
facility;
(2) Is 18 years old or
older; and
(3) Has successfully
completed, at the expense of the participating facility, 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 § 1 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 participating
facilities 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. A participating facility:
(1) Shall ensure that there is a written plan
for the emergency epinephrine program that:
(a) Is approved annually, in writing, by a
health supervisor;
(b) Is on file at
the participating facility 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 participating facility 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 participating facility 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. A participating facility shall
ensure that an incident that occurred on the premises of the facility that
involved the administration of auto-injectable epinephrine by a certificate
holder or agent is reported:
(1) Immediately
to the 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.
