| (a) Purpose. The purpose of this section is to allow
pharmacists to administer epinephrine through an auto-injector device
to a patient in an emergency situation as authorized in Chapter 562
of the Act.
(b) Definitions. The following words and terms, when
used in this section, shall have the following meanings, unless the
context clearly indicates otherwise.
(1) Act--The Texas Pharmacy Act, Chapter 551 - 569,
Occupations Code, as amended.
(2) Administer--The direct application of a prescription
drug to the body of an individual by any means, including injection,
by a pharmacist.
(3) Anaphylaxis--A sudden, severe, and potentially
life-threatening allergic reaction that occurs when a person is exposed
to an allergen. Symptoms may include shortness of breath, wheezing,
difficulty breathing, difficulty talking or swallowing, hives, itching,
swelling, shock, or asthma. Causes may include, but are not limited
to, an insect sting, food allergy, drug reaction, and exercise.
(4) Epinephrine auto-injector--A disposable drug delivery
system that contains a premeasured single dose of epinephrine that
is used to treat anaphylaxis in an emergency situation.
(c) Administration requirements.
(1) Pharmacists may administer epinephrine through
an auto-injector to a patient in an emergency situation.
(2) The authority of a pharmacist to administer epinephrine
through an auto-injector may not be delegated.
(3) Epinephrine administered by a pharmacist under
the provisions of this section shall be in the legal possession of
a pharmacist or the legal possession of a pharmacy which shall be
the pharmacy responsible for drug accountability, including the maintenance
of records of administration of the epinephrine.
(d) Limitation on liability.
(1) A pharmacist who in good faith administers epinephrine
through an auto-injector in accordance with this section and Chapter
562 of the Act is not liable for civil damages for an act performed
in the administration unless the act is willfully or wantonly negligent.
(2) A pharmacist may not receive remuneration for the
administration of epinephrine through an auto-injector but may seek
reimbursement for the cost of the epinephrine auto-injector.
(3) The administration of epinephrine through an auto-injector
to a patient in accordance with the requirements of this section and
Chapter 562 of the Act does not constitute the unlawful practice of
any health care profession.
(e) Notifications.
(1) A pharmacist who administers epinephrine through
an auto-injector to a patient shall report the use to the patient's
primary care physician, as identified by the patient, as soon as practical,
but in no event more than 72 hours from the time of administering
the epinephrine.
(2) Immediately, after administering the epinephrine
auto-injector, the pharmacist shall ensure that 911 is called and
the patient is evaluated by emergency personnel for possible transfer
to the nearest emergency department for additional evaluation, monitoring,
and treatment.
(3) The notifications required in paragraph (1) of
this subsection shall include the:
(A) name of the patient;
(B) age of the patient if under 8 years of age;
(C) name and manufacturer of the epinephrine auto-injector;
(D) date the epinephrine was administered;
(E) name and title of the person administering the
epinephrine; and
(F) name, address, and telephone number of the pharmacy.
(f) Records.
(1) The notification required to be made under this
section shall be kept by the pharmacy and such records shall be available
for at least two years from the date of such record, for inspecting
and copying by the board or its representative and to other authorized
local, state, or federal law enforcement or regulatory agencies.
(2) The notification may be maintained in an alternative
data retention system, such as a data processing system or direct
imaging system provided:
(A) the records maintained in the alternative system
contain all of the information required on the manual record; and
(B) the data processing system is capable of producing
a hard copy of the record upon request of the board, its representative,
or other authorized local, state, or federal law enforcement or regulatory
agencies.
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