| (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.
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