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TITLE 22EXAMINING BOARDS
PART 15TEXAS STATE BOARD OF PHARMACY
CHAPTER 291PHARMACIES
SUBCHAPTER GSERVICES PROVIDED BY PHARMACIES
RULE §291.121Remote Pharmacy Services

      (iii) if prescription drug records are maintained in a data processing system, the system shall have a workable (electronic) data retention system which can produce a separate audit trail of drug usage by the provider pharmacy and each remote site for the preceding two years as specified in §291.34(e) of this title.

    (B) Prescriptions. Prescription drug orders shall meet the requirements of §291.34(b) of this title.

    (C) Records of dispensing. Dispensing records for a prescription drug order shall be maintained by the provider pharmacy in the manner required by §291.34(d) or (e) of this title.

    (D) Transaction information.

      (i) The automated pharmacy system shall electronically record all transactions involving drugs stored in, removed, or dispensed from the system.

      (ii) Records of dispensing from an automated pharmacy system for a patient shall be maintained by the providing pharmacy and include the:

        (I) identity of the system accessed;

        (II) identification of the individual accessing the system;

        (III) date of transaction;

        (IV) name, strength, dosage form, and quantity of drug accessed; and

        (V) name of the patient for whom the drug was accessed.

      (iii) Records of stocking or removal from an automated pharmacy system shall be maintained by the pharmacy and include the:

        (I) date;

        (II) name, strength, dosage form, and quantity of drug stocked or removed;

        (III) name, initials, or identification code of the person stocking or removing drugs from the system; and

        (IV) name, initials, or identification code of the pharmacist who checks and verifies that the system has been accurately filled.

    (E) Patient medication records. Patient medication records shall be created and maintained by the provider pharmacy in the manner required by §291.34(c) of this title.

    (F) Inventory.

      (i) A provider pharmacy shall:

        (I) keep a record of all drugs sent to and returned from a remote site separate from the records of the provider pharmacy and from any other remote site's records; and

        (II) keep a perpetual inventory of controlled substances and other drugs required to be inventoried under §291.17 of this title (relating to Inventory Requirements) that are received and dispensed or distributed from each remote site.

      (ii) As specified in §291.17 of this title, a provider pharmacy shall conduct an inventory at each remote site. The following is applicable to this inventory.

        (I) The inventory of each remote site and the provider pharmacy shall be taken on the same day.

        (II) The inventory of each remote site shall be included with, but listed separately from, the drugs of other remote sites and separately from the drugs of the provider pharmacy.

(b) Remote pharmacy services using emergency medication kits.

  (1) Purpose. The purpose of this section is to provide standards for the provision of pharmacy services by a Class A or Class C pharmacy in a facility that is not at the same location as the Class A or Class C pharmacy through an emergency medication kit as outlined in §562.108 of the Texas Pharmacy Act.

  (2) Definitions. The following words and terms, when used in this subsection, shall have the following meanings, unless the context clearly indicates otherwise. All other words and terms shall have the meanings defined in the Act or §291.31 of this title.

    (A) Automated pharmacy system--A mechanical system that dispenses prescription drugs and maintains related transaction information.

    (B) Emergency medication kits--Controlled substances and dangerous drugs maintained by a provider pharmacy to meet the emergency medication needs of a resident:

      (i) at an institution licensed under Chapter 242 or 252, Health and Safety Code; or

      (ii) at an institution licensed under Chapter 242, Health and Safety Code and that is a veterans home as defined by the §164.002, Natural Resources Code, if the provider pharmacy is a United States Department of Veterans Affairs pharmacy or another federally operated pharmacy.

    (C) Prepackaging--The act of repackaging and relabeling quantities of drug products from a manufacturer's original commercial container, or quantities of unit dosed drugs, into another cartridge or container for dispensing by a pharmacist using an emergency medication kit.

    (D) Provider pharmacy--The community pharmacy (Class A), the institutional pharmacy (Class C), the non-resident pharmacy (Class E) located not more than 20 miles from an institution licensed under Chapter 242 or 252, Health and Safety Code, or the United States Department of Veterans Affairs pharmacy or another federally operated pharmacy providing remote pharmacy services.

    (E) Remote pharmacy service--The provision of pharmacy services, including the storage and dispensing of prescription drugs, in remote sites.

    (F) Remote site--A facility not located at the same location as a Class A, Class C, Class E pharmacy or a United States Department of Veterans Affairs pharmacy or another federally operated pharmacy, at which remote pharmacy services are provided using an emergency medication kit.

  (3) General requirements.

    (A) A provider pharmacy may provide remote pharmacy services using an emergency medication kit to an institution regulated under Chapter 242, or 252, Health and Safety Code.

    (B) A provider pharmacy may provide remote pharmacy services at more than one remote site.

    (C) A provider pharmacy shall not place an emergency medication kit in a remote site which already has a kit from another provider pharmacy except as provided by paragraph (4)(B)(iii) of this subsection.

    (D) A provider pharmacy which is licensed as an institutional (Class C) or a non-resident (Class E) pharmacy is required to comply with the provisions of §§291.31 - 291.34 of this title and this section.

    (E) The pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy operations involving the emergency medication kit located at the remote site including supervision of the emergency medication kit and compliance with this section.

  (4) Operational standards.

    (A) Application for permission to provide pharmacy services using an emergency medication kit.

      (i) A Class A, Class C, or Class E pharmacy shall file a completed application containing all information required by the board to provide remote pharmacy services using an emergency medication kit.

      (ii) Such application shall be resubmitted every two years in conjunction with the application for renewal of the provider pharmacy's license.

      (iii) Upon approval of the application, the provider pharmacy will be sent a certificate which must be displayed at the remote site.

    (B) Notification requirements.

      (i) A provider pharmacy shall notify the board in writing within ten days of a discontinuance of service, or closure of:

        (I) a remote site where an emergency medication kit is operated by the pharmacy; or

        (II) a remote pharmacy service at a remote site.

      (ii) A provider pharmacy shall comply with appropriate federal and state controlled substance registrations for each remote site if controlled substances are maintained within an emergency medication kit at the facility.

      (iii) If more than one provider pharmacy provides an emergency kit to a remote site, the provider pharmacies must enter into a written agreement as to the emergency medications supplied by each pharmacy. The provider pharmacies shall not duplicate drugs stored in the emergency medication kits. The written agreement shall include reasons why an additional pharmacy is required to meet the emergency medication needs of the residents of the institution.

      (iv) A provider pharmacy shall file a change of location and/or name of a remote site as specified in §291.3 of this title.

    (C) Environment/Security.

      (i) Emergency medication kits shall have adequate security and procedures to:

        (I) prohibit unauthorized access;

        (II) comply with federal and state laws and regulations; and

        (III) maintain patient confidentiality.

      (ii) Access to the emergency medication kit shall be limited to pharmacists and licensed healthcare personnel employed by the facility.

      (iii) Drugs shall be stored in compliance with the provisions of §291.15 and §291.33(f)(2) of this title including the requirements for temperature and handling outdated drugs.

    (D) Prescription dispensing and delivery.

      (i) Drugs in the emergency medication kit shall be accessed for administration to meet the emergency medication needs of a resident of the remote site pursuant to an order from a practitioner. The prescription drug order for the drugs used from the emergency medication kit shall be forwarded to the provider pharmacy in a manner authorized by §291.34(b) of this title.

      (ii) The remote site shall notify the provider pharmacy of each entry into an emergency medication kit. Such notification shall meet the requirements of paragraph (5)(D)(ii) of this subsection.

    (E) Drugs.

      (i) The contents of an emergency medication kit:

        (I) may consist of dangerous drugs and controlled substances; and

        (II) shall be determined by the consultant pharmacist, pharmacist-in-charge of the provider pharmacy, medical director, and the director of nurses and limited to those drugs necessary to meet the resident's emergency medication needs. For the purpose of this subsection, this shall mean a situation in which a drug cannot be supplied by a pharmacy within a reasonable time period.

      (ii) When deciding on the drugs to be placed in the emergency medication kit, the consultant pharmacist, pharmacist-in-charge of the provider pharmacy, medical director, and the director of nurses must determine, select, and record a prudent number of drugs for potential emergency incidents based on:

        (I) clinical criteria applicable to each facility's demographics;

        (II) the facility's census; and

        (III) the facility's healthcare environment.

      (iii) A current list of the drugs stored in each remote site's emergency medication kit shall be maintained by the provider pharmacy and a copy kept with the emergency medication kit.

      (iv) An automated pharmacy system may be used as an emergency medication kit provided the system limits emergency access to only those drugs approved for the emergency medication kit.

      (v) Drugs for use in an emergency medication kit shall be packaged in the original manufacturer's container or prepackaged in the provider pharmacy and labeled in compliance with the board's prepackaging requirements for the class of pharmacy.

    (F) Stocking emergency medication kits.

      (i) Stocking of drugs in an emergency medication kit shall be completed at the provider pharmacy or remote site by a pharmacist, pharmacy technician, or pharmacy technician trainee under the direct supervision of a pharmacist, except as provided in clause (ii) of this subparagraph.

      (ii) If the emergency medication kit is an automated pharmacy system which uses bar-coding, microchip, or other technologies to ensure that the containers or unit dose drugs are accurately loaded, the prepackaging of the containers or unit dose drugs shall occur at the provider pharmacy unless provided by an FDA approved repackager. The prepackaged containers or unit dose drugs may be sent to the remote site to be loaded into the machine by personnel designated by the pharmacist-in-charge provided:

        (I) a pharmacist verifies the container or unit dose drug has been properly filled and labeled;

        (II) the individual containers or unit dose drugs are transported to the remote site in a secure, tamper-evident container; and

        (III) the automated pharmacy system uses bar-coding, microchip, or other technologies to ensure that the containers or unit dose drugs are accurately loaded in the automated pharmacy system.

      (iii) All drugs to be stocked in the emergency medication kit shall be delivered to the remote site by the provider pharmacy.

    (G) Policies and procedures of operation.

      (i) A provider pharmacy that provides pharmacy services through an emergency medication kit at a remote site shall operate according to written policies and procedures. The policy and procedure manual shall include, but not be limited to, the following:

        (I) duties which may only be performed by a pharmacist;

        (II) a copy of the written contract or agreement between the pharmacy and the facility which outlines the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract in compliance with federal and state laws and regulations;

        (III) date of last review/revision of the policy and procedure manual; and

Cont'd...

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