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<regulation prefix="Regulation" num=".06" citation="COMAR 10.34.28.06" title_num="10" subtitle_num="34" chapter_num="28" heading="Usage Requirements for Remote Automated Medication Systems.">
  <paragraph num="A.">
    <text>A remote automated medication system may only be used if:</text>
    <paragraph num="(1)">
      <text>Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A responsible pharmacist has been designated by the permit holder to supervise and manage the operations of the remote automated medication system;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Except for starter doses, a licensed pharmacist reviews each order for medication:</text>
      <paragraph num="(a)">
        <text>After the order has been entered into the system; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Before the system permits access to the medication;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>The permit holder ensures that:</text>
      <paragraph num="(a)">
        <text>Patients have prompt access to pharmacy services necessary for the provision of good pharmaceutical care as defined in Health Occupations Article, §12-101, Annotated Code of Maryland;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The remote automated medication system maintains the integrity of the information in the system and protects patient confidentiality; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The remote automated medication system is subject to a quality assurance program in accordance with Regulation .10 of this chapter; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>It is designed to distribute medications in a licensed health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A starter dose, or a dose in response to an emergency, may be distributed without prior review by a pharmacist of the order if the pharmacist reviews the order within 24 hours of removal from the remote automated medication system.</text>
  </paragraph>
  <paragraph num="C.">
    <text>If a licensed pharmacist is not physically present where the remote automated medication system is located, the pharmacist shall have access to the system by electronic and visual means in order to ensure the safe and efficient operation of the system.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Remote automated medication systems shall operate in a manner which:</text>
    <paragraph num="(1)">
      <text>Unless packaging and labeling for a specific patient, limits simultaneous access to multiple:</text>
      <paragraph num="(a)">
        <text>Drug strengths;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Dosage forms; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Drug entities;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Prevents access to medication not ordered for the patient; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Safeguards against the misidentification of medications, dosages, and dosage forms by those accessing the remote automated medication system.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>The requirements listed in §D(1) and (2) of this regulation do not apply to automated supply towers which contain:</text>
    <paragraph num="(1)">
      <text>Noncontrolled medications that are:</text>
      <paragraph num="(a)">
        <text>Refrigerated;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Bulk; or</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Intravenous fluids; or</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Prescription devices.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>A remote automated medication system may be used only if the system:</text>
    <paragraph num="(1)">
      <text>Uses positive drug identification, such as bar code technology, to ensure accuracy in:</text>
      <paragraph num="(a)">
        <text>Loading and selection of medications in the pharmacy for stocking and replenishment of the remote automated medication system; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Loading medications into the remote automated medication system where it is located;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Has electronic reporting capability regarding the identity of persons with access to the system and regarding medications removed from the system;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Restricts access to medications to a licensed pharmacist or an individual authorized to administer medication under Health Occupation Article, Annotated Code of Maryland; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Before administration of a medication to a patient, provides:</text>
      <paragraph num="(a)">
        <text>A picture of the medication, if available; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>If a picture is not available, a written description of the medication specifically by color, shape, and unique manufacturer markings.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>The permit holder shall ensure that the health care facility where the remote automated medication system is located provides, at a minimum:</text>
    <paragraph num="(1)">
      <text>A licensed pharmacist available for consultation 24 hours per day;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Technical assistance regarding operation of the system available 24 hours per day; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A quality assurance program as set forth in Regulation .10 of this chapter.</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>A permit holder shall indicate on the initial, renewal, and reinstatement applications:</text>
    <paragraph num="(1)">
      <text>Whether the permit holder operated a remote automated medication system; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Any other information regarding the system that the Board considers necessary to determine compliance with this chapter.</text>
    </paragraph>
  </paragraph>
</regulation>