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RULE §511.47Pharmaceutical Services

(a) A limited services rural hospital (LSRH) shall provide pharmaceutical services that meet the needs of the patients. The LSRH shall provide a pharmacy that is licensed, as required, by the Texas State Board of Pharmacy. Pharmacy services shall comply with all applicable statutes and rules.

(b) The LSRH pharmacy shall be directed by a licensed pharmacist.

(c) The LSRH medical staff shall develop policies and procedures that minimize drug errors. This function may be delegated to the LSRH's organized pharmaceutical services.

(d) The LSRH pharmacy or drug storage area shall be administered in accordance with accepted professional principles.

(e) Standards of practice as defined by state law shall be followed regarding the provision of pharmacy services.

(f) The pharmaceutical services shall have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services.

  (1) The staff shall be sufficient in number and training to respond to the pharmaceutical needs of the patient population being served. There shall be an arrangement for emergency services.

  (2) Employees shall provide pharmaceutical services within the scope of their license and education.

(g) Drugs and biologicals shall be properly stored to ensure ventilation, light, security, and temperature controls.

(h) Records shall have sufficient detail to follow the flow of drugs from entry through dispensation.

(i) There shall be adequate controls over all drugs and medications, including the floor stock. Drug storage areas shall be approved by the pharmacist, and floor stock lists shall be established.

(j) Inspections of drug storage areas shall be conducted throughout the LSRH under pharmacist supervision.

(k) The LSRH shall have a drug recall procedure.

(l) A full-time, part-time, or consulting pharmacist shall be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.

  (1) Direction of pharmaceutical services may not require on-premises supervision but may be accomplished through regularly scheduled visits in accordance with state law.

  (2) A job description or other written agreement shall clearly define the responsibilities of the pharmacist.

(m) The LSRH shall keep current and accurate records of the receipt and disposition of all scheduled drugs.

  (1) There shall be a record system in place that provides the information on controlled substances in a readily retrievable manner that is separate from the patient record.

  (2) Records shall trace the movement of scheduled drugs throughout the services, documenting utilization or wastage.

  (3) The pharmacist shall be responsible for determining that all drug records are in order and that an account of all scheduled drugs is maintained and reconciled with written orders.

(n) In order to provide patient safety, drugs and biologicals shall be controlled and distributed in accordance with applicable standards of practice, consistent with federal and state laws.

(o) All compounding, packaging, and dispensing of drugs and biologicals shall be under the supervision of a pharmacist and performed consistent with federal and state laws.

(p) All drugs and biologicals shall be kept in a secure area and locked when appropriate.

  (1) The LSRH shall adopt, implement, and enforce a policy to ensure the safeguarding, transferring, and availability of keys to the locked storage area.

  (2) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. 91-513, 84 Stat. 1236 (21 USC Ch. 13 § 801 et seq.), shall be kept locked within a secure area.

(q) Outdated, mislabeled, or otherwise unusable drugs and biologicals shall not be available for patient use.

(r) When a pharmacist is not available, drugs and biologicals shall be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with federal and state laws.

  (1) There shall be a current list of individuals identified by name and qualifications who are designated to remove drugs from the pharmacy.

  (2) Only amounts sufficient for immediate therapeutic needs shall be removed.

(s) Drugs and biologicals not specifically prescribed as to time or number of doses shall automatically be stopped after a reasonable time that is predetermined by the medical staff.

  (1) Stop order policies and procedures shall be consistent with those of the nursing staff and the medical staff rules and regulations.

  (2) A protocol shall be established by the medical staff for the implementation of the stop order policy, in order that drugs shall be reviewed and renewed, or automatically stopped.

  (3) A system shall be in place to determine compliance with the stop order policy.

(t) Drug administration errors, adverse drug reactions, and incompatibilities shall be immediately reported to the attending physician and, if appropriate, to the LSRH-wide quality assessment and performance improvement program. There shall be a mechanism in place for capturing, reviewing, and tracking medication errors and adverse drug reactions.

(u) Abuses and losses of controlled substances shall be reported, in accordance with applicable federal and state laws, to the individual responsible for the pharmaceutical services, and to the chief executive officer, as appropriate.

(v) Information relating to drug interactions and information on drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration shall be immediately available to the professional staff.

  (1) A pharmacist shall be readily accessible by telephone or other means to discuss drug therapy, interactions, side effects, dosage, assist in drug selection, and assist in the identification of drug induced problems.

  (2) There shall be staff development programs on drug therapy available to facility staff to cover such topics as new drugs added to the formulary, how to resolve drug therapy problems, and other general information as the need arises.

  (3) The medical staff shall establish a formulary system to ensure quality pharmaceuticals at reasonable costs.

(w) Blood transfusions, blood products, and intravenous medications must be administered in accordance with state law and approved medical staff policies and procedures.

(x) Orders given orally for drugs and biologicals must be followed by a written order, signed by the prescribing physician or other authorized prescriber.

(y) The LSRH shall have a procedure for reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs.

Source Note: The provisions of this §511.47 adopted to be effective October 5, 2023, 48 TexReg 5668

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