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 §19.1906 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 §19.1906 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 §19.1503 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 §19.1207 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.

Source Note: The provisions of this §554.1501 adopted to be effective May 1, 1995, 20 TexReg 2054; amended to be effective July 1, 2002, 27 TexReg 5524; amended to be effective March 24, 2020, 45 TexReg 2025; transferred effective January 15, 2021, as published in the Texas Register December 11, 2020, 45 TexReg 8871