Current through Reg. 50, No. 13; March 28, 2025
A licensed-only facility must assist the resident in
obtaining routine drugs and biologicals and make emergency drugs readily
available, or obtain them under an agreement described in §
554.1906 of this chapter (relating
to Use of Outside Resources). A Medicaid-certified facility must provide
routine and emergency drugs and biologicals to its residents, or obtain them
under an agreement described in §
554.1906 of this chapter.
(1) Methods and procedures. The facility may
permit unlicensed personnel to administer drugs, but only under the general
supervision of a licensed nurse. The unlicensed individual must be a nursing
student, a medication aide student, or a medication aide with a current permit
issued by HHSC.
(2) Accuracy in
service delivery. A facility must provide pharmaceutical services (including
procedures that assure the accurate acquiring, receiving, dispensing, and
administering of all drugs and biologicals) to meet the needs of each
resident.
(3) Service consultation.
The facility must employ or obtain the services of a pharmacist, currently
licensed by the Texas State Board of Pharmacy and in good standing, who:
(A) provides consultation on all aspects of
the provision of pharmacy services in the facility;
(B) establishes a system of records of
receipt and disposition of all controlled drugs in sufficient detail to enable
an accurate reconciliation;
(C)
determines that drug records are in order and that an account of all controlled
drugs is maintained and periodically reconciled; and
(D) adheres to requirements in §
554.1503 of this subchapter
(relating to Additional Supervision and Consultation
Requirements).
(4) Drug
regimen review.
(A) The drug regimen of each
resident must be reviewed at least once a month by a licensed pharmacist. The
consultant pharmacist's drug regimen review must be maintained in the
resident's clinical record. This review must include a review of the resident's
medical chart.
(B) A psychotropic
drug is any drug that affects brain activities associated with mental processes
and behavior. Psychotropic drugs include psychoactive medications as defined in
§
554.1207 of this chapter (relating
to Prescription of Psychoactive Medication). These drugs include drugs in the
following categories:
(C) The
pharmacist must report any irregularities to the attending physician and the
director of nursing, and these reports must be acted upon.
(i) Irregularities include any drug that
meets the criteria set forth in paragraph (5) of this subsection.
(ii) Any irregularities noted by the
pharmacist during this review must be documented on a separate, written report
that is sent to the attending physician and the facility's medical director and
director of nursing and lists the resident's name, the relevant drug, and the
irregularity the pharmacist identified.
(iii) The attending physician must document
in the resident's clinical record that the identified irregularity has been
reviewed and what, if any, action has been taken to address it. If there is to
be no change in the medication, the attending physician must document the
physician's rationale in the resident's clinical record.
(D) The facility must develop and maintain
written policies and procedures for the monthly drug regiment review that
include time frames for the different steps in the process and steps the
pharmacist must take when the pharmacist identifies an irregularity that
requires urgent action to protect the resident.
(5) Unnecessary Drugs. Each resident's drug
regimen must be free from unnecessary drugs. An unnecessary drug is any drug
when used:
(A) in excessive dose (including
duplicate drug therapy);
(B) for
excessive duration;
(C) without
adequate monitoring;
(D) without
adequate indications for its use;
(E) in the presence of adverse consequences
which indicate the dose should be reduced or discontinued; or
(F) in any combination of the reasons stated
in subparagraphs (A) - (E) of the paragraph.
(6) Psychotropic drugs. Based on a
comprehensive assessment of a resident, the facility must ensure that:
(A) a resident who has not used psychotropic
drugs is not given these drugs unless the medication is necessary to treat a
specific condition as diagnosed and documented in the resident's clinical
record;
(B) a resident who uses
psychotropic drugs receives gradual dose reductions and behavioral
interventions, unless clinically contraindicated, in an effort to discontinue
use of these drugs;
(C) a resident
does not receive psychotropic drugs pursuant to a PRN order unless that
medication is necessary to treat a diagnosed specific condition that is
documented in the resident's clinical record; and
(D) PRN orders for psychotropic drugs are
limited to 14 days. Except as provided in subparagraph (E) of this paragraph,
if the attending physician or prescribing practitioner believes that it is
appropriate for the PRN order to be extended beyond 14 days, the physician must
document the rationale in the resident's clinical record and indicate the
duration for the PRN order.
(E) PRN
orders for anti-psychotic drugs are limited to 14 days and cannot be renewed
unless the attending physician or prescribing practitioner evaluates the
resident for the appropriateness of the medication.
(7) Medication errors. The facility must
ensure that:
(A) the medication error rates
are not 5 percent or greater; and
(B) the residents are free of any significant
medication errors.
(8)
Labeling of drugs and biologicals. Drugs and biologicals used in the facility
must be labeled in accordance with currently accepted professional principals
and in compliance with the state laws and regulations, including the
appropriate accessory and cautionary instructions and the expiration date when
applicable.
(9) Storage of drugs
and biologicals.
(A) In accordance with state
and federal laws, the facility must store all drugs and biologicals in locked
compartments under proper temperature controls and permit only authorized
personnel to have access to the keys.
(B) The facility must provide separately
locked, permanently affixed compartments for storage of controlled drugs,
listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control
Act of 1976, and of other drugs subject to abuse, except when the facility uses
single-unit-package drug distribution systems in which the quantity stored is
minimal and a missing dose can be readily detected.
