| (a) Purpose. The purpose of this section is to provide
standards for the maintenance of records of a pharmacist engaged in
the provision of drug therapy management as authorized in Chapter
157 of the Medical Practice Act and §554.005 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) Act--The Texas Pharmacy Act, Chapter 551 - 566
and 568 - 569, Occupations Code, as amended.
(2) Board--The Texas State Board of Pharmacy.
(3) Confidential record--Any health-related record
maintained by a pharmacy or pharmacist, such as a patient medication
record, prescription drug order, or medication order.
(4) Drug therapy management--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:
(A) collecting and reviewing patient drug use histories;
(B) ordering or performing routine drug therapy related
patient assessment procedures including temperature, pulse, and respiration;
(C) ordering drug therapy related laboratory tests;
(D) implementing or modifying drug therapy following
diagnosis, initial patient assessment, and ordering of drug therapy
by a physician as detailed in the protocol; or
(E) any other drug therapy related act delegated by
a physician.
(5) Medical Practice Act--The Texas Medical Practice
Act, Subtitle B, Occupations Code, as amended.
(6) 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
drug therapy management;
(ii) a statement identifying the individual pharmacist
authorized to dispense drugs and to engage in drug therapy management
as delegated by the physician;
(iii) 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 involved,
drugs, and types 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;
(iv) 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
(v) 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.
(B) 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.
(c) Physician delegation to a pharmacist.
(1) As specified in Chapter 157 of the Texas Medical
Practices Act, a physician may delegate to a properly qualified and
trained pharmacist acting under adequate physician 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.
(2) A delegation under paragraph (1) of this subsection
may include:
(A) the implementation or modification of a patient's
drug therapy under a protocol, if:
(i) the delegation follows a diagnosis, initial patient
assessment, and drug therapy order by the physician; and
(ii) the pharmacist maintains a copy of the protocol
for inspection until at least the seventh anniversary of the expiration
date of the protocol; or
(B) the authority to sign a prescription drug order
for dangerous drugs, if:
(i) the delegation follows a diagnosis, initial patient
assessment, and drug therapy order by the physician;
(ii) the pharmacist practices in a federally qualified
health center, hospital, hospital-based clinic, or an academic health
care institution; and
(iii) the federally qualified health center, hospital,
hospital-based clinic, or academic health care institution in which
the pharmacist practices has bylaws and a medical staff policy that
permit a physician to delegate to a pharmacist the management of a
patient's drug therapy.
(3) A pharmacist who signs a prescription for a dangerous
drug under authority granted under paragraph (2) of this subsection
shall:
(A) notify the board that a physician has delegated
the authority to sign a prescription for dangerous drugs on an application
provided by the board and prior to signing any prescription for a
dangerous drug;
(B) submit a copy of the written protocol to the board
at the time of initial notification;
(C) submit an updated copy of the written protocol
to the board if the protocol has changed within 10 days of the change;
and
(D) include the pharmacist's name, address, and telephone
number as well as the name, address, and telephone number of the delegating
physician on each prescription for a dangerous drug signed by the
pharmacist.
(4) The board shall post the following information
on its website:
(A) the name and license number of each pharmacist
who has notified the board that a physician has delegated authority
to sign a prescription for a dangerous drug; and
(B) the name and address of the physician who delegated
the authority to the pharmacist.
(d) Pharmacist Training Requirements.
(1) Initial requirements. A pharmacist shall maintain
and provide to the Board within 24 hours of request a statement attesting
to the fact that the pharmacist has within the last year:
(A) completed at least six hours of continuing education
related to drug therapy offered by a provider approved by the Accreditation
Council for Pharmacy Education (ACPE); or
(B) engaged in drug therapy management as allowed under
previous laws or rules. A statement from the physician supervising
the acts shall be sufficient documentation.
(2) Continuing requirements. A pharmacist engaged in
drug therapy management shall annually complete six hours of continuing
education related to drug therapy offered by a provider approved by
the Accreditation Council for Pharmacy Education (ACPE). (These hours
may be applied towards the hours required for renewal of a license
to practice pharmacy.)
(e) Supervision. Physician supervision shall be as
specified in the Medical Practice Act, Chapter 157 and shall be considered
adequate if the delegating physician:
(1) is responsible for the formulation or approval
of the written protocol and any patient-specific deviations 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 informs 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; and
(6) determines that the pharmacist to whom the physician
is delegating drug therapy management establishes and maintains a
pharmacist-patient relationship with the patient.
(f) Records.
Cont'd... |
