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<section article="gho" article_name="Health Occupations" number="12-605" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6" subtitle_name="Board Regulation of Drugs, Medicines, and Other Products">
  <level label="a">
    <level label="1">
      <text>In this section the following words have the meanings indicated.</text>
    </level>
    <level label="2">
      <text>“Health care facility” means a related institution as defined in § 19–301 of the Health – General Article.</text>
    </level>
    <level label="3">
      <text>“Remote automated medication system” means an automated mechanical system that is located in a health care facility that does not have an on–site pharmacy and in which medication is stored in a manner that may be patient–specific.</text>
    </level>
    <level label="4">
      <text>“Starter dose” means a dose of medication removed from a remote automated medication system within the first 24 hours after it is ordered.</text>
    </level>
  </level>
  <level label="b">
    <level label="1">
      <text>A pharmacist shall be responsible for the safe and efficient dispensing, repackaging, delivery, control, bar coding, transaction records, dispensation records, labeling, and accountability for all medications in a remote automated medication system located in a health care facility that does not have a pharmacy present on–site.</text>
    </level>
    <level label="2">
      <text>If a pharmacist is not physically present where the remote automated medication system is located in a health care facility, the pharmacist shall have access to the system by electronic and visual means in order to ensure the safe and efficient dispensing, repackaging, delivery, control, bar coding, transaction records, dispensation records, labeling, and accountability for all medications in the system.</text>
    </level>
  </level>
  <level label="c">
    <text>If a health care facility uses a remote automated medication system, a pharmacist shall review for accuracy, completeness, and appropriateness all medication orders after being entered into the system.</text>
  </level>
  <level label="d">
    <level label="1">
      <text>If a remote automated medication system, the pharmacy permit holder that manages the system, and the health care facility where the system is located meet the requirements of this subsection:</text>
      <level label="i">
        <text>A health care facility that uses a system does not need to have a pharmacist physically present to review the selection, packaging, or repackaging of medications by the system;</text>
      </level>
      <level label="ii">
        <text>If the starter dose is reviewed by a pharmacist within 24 hours of delivery from a system, a system may deliver a starter dose or a dose in response to an emergency without prior review by a pharmacist; and</text>
      </level>
      <level label="iii">
        <text>A system may allow simultaneous access to multiple drug strengths, dosage forms, or drug entities if contained within a patient–specific package.</text>
      </level>
    </level>
    <level label="2">
      <text>A remote automated medication system shall at least:</text>
      <level label="i">
        <text>Use bar code technology to ensure accuracy in loading and selection of medications in the system;</text>
      </level>
      <level label="ii">
        <text>Have electronic reporting capability regarding the identity of all persons with access to the system and regarding all medications removed from the system; and</text>
      </level>
      <level label="iii">
        <text>Before administration of a medication to a patient by an individual authorized to administer medication under this article, provide:</text>
        <level label="1">
          <text>A picture of the medication if available; or</text>
        </level>
        <level label="2">
          <text>If a picture is not available, a written report that describes the medication.</text>
        </level>
      </level>
    </level>
    <level label="3">
      <text>The health care facility where the system is located shall have at least:</text>
      <level label="i">
        <text>A pharmacist available for consultation 24 hours per day;</text>
      </level>
      <level label="ii">
        <text>Technical assistance regarding operation of the system available 24 hours per day; and</text>
      </level>
      <level label="iii">
        <text>A quality assurance program as described under subsection (e) of this section.</text>
      </level>
    </level>
    <level label="4">
      <text>The pharmacy permit holder that manages a remote automated medication system shall provide a comprehensive training program to all persons with access to the system.</text>
    </level>
  </level>
  <level label="e">
    <level label="1">
      <text>A pharmacist that operates a remote automated medication system, in consultation with the health care facility where the system is located, shall develop and implement a quality assurance program in accordance with regulations adopted by the Board.</text>
    </level>
    <level label="2">
      <text>The quality assurance program developed under this subsection shall include:</text>
      <level label="i">
        <text>Policies and procedures at both the pharmacy where the system receives an order and the health care facility where the system administers the medication regarding operation of the system;</text>
      </level>
      <level label="ii">
        <text>Daily inspection of the integrity of the system;</text>
      </level>
      <level label="iii">
        <text>A plan for addressing medication errors;</text>
      </level>
      <level label="iv">
        <text>A plan for reviewing incidents regarding inappropriate use and access to the system;</text>
      </level>
      <level label="v">
        <text>Proper labeling procedures that comply with applicable State and federal laws;</text>
      </level>
      <level label="vi">
        <text>Policies and procedures for the safe handling and return of unused medications; and</text>
      </level>
      <level label="vii">
        <text>Any other requirements determined by the Board and set forth in regulations.</text>
      </level>
    </level>
  </level>
  <level label="f">
    <level label="1">
      <text>A pharmacist that operates a remote automated medication system shall limit access to the system to individuals authorized to access the system by requiring individual security codes for all functions.</text>
    </level>
    <level label="2">
      <text>A record shall be kept of each transaction containing user identification information.</text>
    </level>
  </level>
  <level label="g">
    <level label="1">
      <text>A pharmacist who operates a remote automated medication system shall maintain maintenance logs and repair records for the system.</text>
    </level>
    <level label="2">
      <text>In a power outage or otherwise unforeseen situation, a pharmacist shall ensure that:</text>
      <level label="i">
        <text>A back–up power source for the system is available by a connection with the health care facility’s generator; and</text>
      </level>
      <level label="ii">
        <text>Only a registered nurse or a licensed practical nurse has access to the medications contained within the system.</text>
      </level>
    </level>
  </level>
</section>
