Current through Reg. 49, No. 38; September 20, 2024
(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.
