Current through Reg. 49, No. 38; September 20, 2024
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:
(i) anti-psychotic;
(ii) anti-depressant;
(iii) anti-anxiety; and
(iv) hypnotic.
(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.
