| (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.
|
| Source Note: The provisions of this §295.13 adopted to be effective April 7, 1997, 22 TexReg 3112; amended to be effective December 19, 2001, 26 TexReg 10313; amended to be effective June 12, 2005, 30 TexReg 3209; amended to be effective December 6, 2009, 34 TexReg 8721; amended to be effective December 9, 2019, 44 TexReg 7546; amended to be effective March 5, 2020, 45 TexReg 1434; amended to be effective March 14, 2021, 46 TexReg 1641 |
