Section 193.16 - Delegated Administration of Immunizations or Vaccinations by a Pharmacist under Written Protocol(a) Purpose. This section is promulgated to promote the efficient administration and regulation of the delegation by physicians to pharmacists of the administration of immunizations or vaccinations under written protocol pursuant to the § 157.001 of the Act (related to Delegation of Certain Functions).(b) Delegation. A physician licensed to practice medicine in Texas may delegate to a properly qualified and trained pharmacist acting under adequate supervision the administration of immunizations and vaccinations authorized by the physician through the physician's order, standing medical order, standing delegation order, or other order or protocol as provided for in this section.(c) Delegated Administration of Immunizations and Vaccinations under Written Protocol. Administration of Immunizations and Vaccinations does not include the selection of drug products not prescribed by the physician unless the drug product is named in the physician initiated protocol.(d) Supervision. Physician supervision shall be considered adequate for purposes of this section if the delegating physician is in compliance with this section and the physician: (1) is responsible for the formulation or approval of the physician's order, standing medical order, standing delegation order, or other order or written protocol and periodically reviews the order or protocol and the services provided to the patient under the order or protocol on a schedule defined in the written protocol;(2) has established a physician-patient relationship with each patient under 14 years of age and referred the patient to the pharmacist;(3) is geographically located so as to be easily accessible to the pharmacist administering the immunization or vaccination;(4) receives, on a schedule defined in the written protocol, a periodic status report on the patient, including any problem or complication encountered; and(5) is available through direct telecommunication for consultation, assistance, and direction.(e) Written protocol. Written protocols for purposes of this section shall mean a physician's order, standing medical order, standing delegation order, or other written order. (1) A written protocol must contain at a minimum the following listed in subparagraphs (A) - (F) of this paragraph: (A) a statement identifying the individual physician authorized to prescribe drugs and responsible for the delegation of administration of immunizations or vaccinations;(B) a statement identifying the individual pharmacist authorized to administer immunizations or vaccinations as delegated by the physician;(C) a statement identifying the location(s) at which the pharmacist may administer immunizations or vaccinations which may not include where the patient resides, except for a licensed nursing home or hospital;(D) a statement identifying the immunizations or vaccinations that may be administered by the pharmacist;(E) 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(F) 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 24 hours of administering the immunization or vaccination.(2) 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 that patient.(f) Review and revision of protocols. (1) At least annually, written protocols shall be reviewed by the physician and, if necessary, revised.(2) Documentation of the administration of immunizations or vaccinations to the patient by a pharmacist shall be reviewed by the physician on the schedule established in the protocol.(g) Construction and interpretation. This section shall not be construed or interpreted to restrict the use of a pre-established health care program or restrict a physician from authorizing the provision of patient care by use of a pre-established health care program if the patient is institutionalized and the care is to be delivered in a licensed hospital with an organized medical staff that has authorized standing delegation orders, standing medical orders, or protocols. This section may not be construed to limit, expand, or change any provision of law concerning or relating to therapeutic drug substitution or administration of medication, including the Texas Pharmacy Act, Texas Occupations Code §§ 554.001 - 554.004.22 Tex. Admin. Code § 193.16
The provisions of this §193.16 adopted to be effective November 7, 2013, 38 TexReg 7711