(a) Purpose. This section is promulgated to promote the efficient administration and regulation of the delegation by physicians to pharmacists of drug therapy management pursuant to §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 performance of specific acts of drug therapy management 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) Drug therapy management. Drug therapy management is the performance of specific acts by pharmacists as authorized by a physician through written protocol. Drug therapy management does not include the selection of drug products not prescribed by the physician unless the drug product is named in the physician initiated protocol or the physician initiated record of deviation from a standing protocol. Drug therapy management may include the following listed in paragraphs (1) - (6) of this subsection:
  (1) collecting and reviewing patient drug use histories;
  (2) ordering or performing routine drug therapy related patient assessment procedures including temperature, pulse, and respiration;
  (3) ordering drug therapy related laboratory tests;
  (4) implementing or modifying drug therapy, including the authority to sign a prescription drug order for dangerous drugs as provided in §157.101(b-1) of the Act, following diagnosis, initial patient assessment, and ordering of drug therapy by a physician, as detailed in the protocol, provided that the pharmacist:
    (A) practices in a hospital, hospital-based clinic or an academic health care institution that has bylaws and a medical staff policy that permit a physician to delegate to a pharmacist the management of a patient's drug therapy;
    (B) provides the name, address, and telephone number of the pharmacist and of the delegating physician on each prescription signed by the pharmacist; and
    (C) the pharmacist provides a copy of the protocol to the Texas State Board of Pharmacy;
  (5) generically equivalent drug selection if the physician's signature does not clearly indicate that the prescription must be dispensed as written; or
  (6) any other drug therapy related act delegated by a physician.
(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 written protocol and any patient-specific deviation from the protocol and review of the written protocol and any patient-specific deviations from the protocol at least annually and the services provided to a patient under the protocol on a schedule defined in the written protocol;
  (2) has established and maintains a physician-patient relationship with each patient provided drug therapy management by a delegated pharmacist and informed the patient that drug therapy will be managed by a pharmacist under written protocol;
  (3) is geographically located so as to be able to be physically present daily to provide medical care and supervision;
  (4) receives, on a schedule defined in the written protocol, a periodic status report on the patient, including any problem or complication encountered;
  (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) - (E) of this paragraph:
    (A) a statement identifying the individual physician authorized to prescribe drugs and responsible for the delegation of drug therapy management;
    (B) a statement identifying the individual pharmacist authorized to dispense drugs and to engage in drug therapy management as delegated by the physician;
    (C) a statement identifying the types of drug therapy management decisions that the pharmacist is authorized to make which shall include:
      (i) a statement of the ailments or diseases, drugs, and type of drug therapy management authorized; and
      (ii) a specific statement of the procedures, decision criteria, or plan the pharmacist shall follow when exercising drug therapy management authority;
    (D) a statement of the activities the pharmacist shall follow in the course of exercising drug therapy management authority, including the method for documenting decisions made and a plan for communication or feedback to the authorizing physician concerning specific decisions made. Documentation shall be recorded within a reasonable time of each intervention and may be performed on the patient medication record, patient medical chart, or in a separate log book; and
    (E) a statement that describes appropriate mechanisms and time schedule for the pharmacist to report to the physician monitoring the pharmacist's exercise of delegated drug therapy management and the results of the drug therapy management.
  (2) A standard protocol may be used, or the attending physician may develop a drug therapy management 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 all services provided to the patient by the 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 Chapter 551.

Source Note: The provisions of this §193.15 adopted to be effective November 7, 2013, 38 TexReg 7711