Texas Administrative Code › Title 22 - EXAMINING BOARDS › Part 15 - TEXAS STATE BOARD OF PHARMACY › Chapter 295 - PHARMACISTS › Section 295.15 - Administration of Immunizations or Vaccinations by a Pharmacist under Written Protocol of Physician

Current through Reg. 49, No. 28; July 12, 2024
(a) Purpose. The
				purpose of this section is to provide standards for pharmacists engaged in the
				administration of immunizations or vaccinations as authorized in Chapter 554 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) ACPE--The Accreditation Council for
				Pharmacy Education.
(2) Act--The
				Texas Pharmacy Act, Chapter 551 - 566 and 568 - 569, Occupations Code, as
				amended.
(3) Administer--The direct
				application of a prescription drug by injection, inhalation, ingestion, or any
				other means to the body of a patient by:
(A) a
				practitioner, an authorized agent under his supervision, or other person
				authorized by law; or
(B) the
				patient at the direction of a practitioner.
(4) Antibody--A protein in the blood that is
				produced in response to stimulation by a specific antigen. Antibodies help
				destroy the antigen that produced them. Antibodies against an antigen usually
				equate to immunity to that antigen.
(5) Antigen--A substance "recognized" by the
				body as being foreign; it results in the production of specific antibodies
				directed against it.
(6) Board--The
				Texas State Board of Pharmacy.
(7)
				Confidential record--Any health-related record that contains information that
				identifies an individual and that is maintained by a pharmacy or pharmacist
				such as a patient medication record, prescription drug order, or medication
				order.
(8) Data communication
				device--An electronic device that receives electronic information from one
				source and transmits or routes it to another (e.g., bridge, router, switch, or
				gateway).
(9) Immunization--The act
				of inducing antibody formation, thus leading to immunity.
(10) Medical Practice Act--The Texas Medical
				Practice Act, Subtitle B, Occupations Code, as amended.
(11) Vaccination--Administration of any
				antigen in order to induce immunity; is not synonymous with immunization since
				vaccination does not imply success.
(12) Vaccine--A specially prepared antigen,
				which upon administration to a person will result in immunity.
(13) Written Protocol--A physician's order,
				standing medical order, standing delegation order, or other order or protocol
				as defined by rule of the Texas Medical Board under the Medical Practice Act.
(A) A written protocol must contain, at a
				minimum, the following:
(i) a statement
				identifying the individual physician authorized to prescribe drugs and
				responsible for the delegation of administration of immunizations or
				vaccinations;
(ii) a statement
				identifying the individual pharmacist authorized to administer immunizations or
				vaccinations as delegated by the physician;
(iii) a statement identifying the location(s)
				(i.e., address) at which the pharmacist may administer immunizations or
				vaccinations;
(iv) a statement
				identifying the immunizations or vaccinations that may be administered by the
				pharmacist;
(v) a statement
				identifying the activities the pharmacist shall follow in the course of
				administering immunizations or vaccinations, including procedures to follow in
				the case of reactions following administration; and
(vi) a statement that describes the content
				of, and the appropriate mechanisms for the pharmacist to report the
				administration of immunizations or vaccinations to the physician issuing the
				written protocol within the time frames specified in this section.
(B) A standard protocol may be
				used or the physician may develop an immunization or vaccination protocol for
				the individual patient. If a standard protocol is used, the physician shall
				record what deviations, if any, from the standard protocol are ordered for the
				patient.