22 Tex. Admin. Code § 295.16 - Administration of Epinephrine by a Pharmacist
(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.
Notes
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