22 Tex. Admin. Code § 295.13 - Drug Therapy Management by a Pharmacist under Written Protocol of a Physician
(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.
(1) Maintenance of records.
(A) Every record required to be kept under
this section shall be kept by the pharmacist and be available, for at least two
years from the date of such record, for inspecting and copying by the board or
its representative and to other authorized local, state, or federal law
enforcement or regulatory agencies.
(B) Records may be maintained in an
alternative data retention system, such as a data processing system or direct
imaging system provided:
(i) the records
maintained in the alternative system contain all of the information required on
the manual record; and
(ii) the
data processing system is capable of producing a hard copy of the record upon
the request of the board, its representative, or other authorized local, state,
or federal law enforcement or regulatory agencies.
(2) Written protocol.
(A) A copy of the written protocol and any
patient-specific deviations from the protocol shall be maintained by the
pharmacist.
(B) A pharmacist shall
document all interventions undertaken under the written protocol within a
reasonable time of each intervention. Documentation may be maintained in the
patient medication record, patient medical chart, or in a separate
log.
(C) 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. A pharmacist shall maintain a copy of any deviations from the standard
protocol ordered by the physician.
(D) Written protocols, including standard
protocols, any patient-specific deviations from a standard protocol, and any
individual patient protocol, shall be reviewed by the physician and pharmacist
at least annually and revised if necessary. Such review shall be documented in
the pharmacist's records. 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) Confidentiality.
(1) In addition to the confidentiality
requirements specified in §
291.27
of this title (relating to Confidentiality) a pharmacist shall comply with:
(A) the privacy provisions of the federal
Health Insurance Portability and Accountability Act of 1996 (Pub.
L. No. 104-191 ) and any rules adopted pursuant to
this act;
(B) the requirements of
Medical Records Privacy contained in Chapter 181, Health and Safety
Code;
(C) the Privacy of Health
Information requirements contained in Chapter 28B of the Insurance Code;
and
(D) any other confidentiality
provisions of federal or state laws.
(2) This section shall not affect or alter
the provisions relating to the confidentiality of the physician-patient
communication as specified in the Medical Practice Act, Chapter 159.
(h) Construction and
Interpretation.
(1) As specified in the
Medical Practice Act, Chapter 157, this section does not 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.
(2) As specified in the Medical Practice Act,
Chapter 157, 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 Act, §554.004.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.