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<regulation prefix="Regulation" num=".05" citation="COMAR 10.34.28.05" title_num="10" subtitle_num="34" chapter_num="28" heading="Usage Requirements for Decentralized Automated Medication Systems.">
  <paragraph num="A.">
    <text>A decentralized 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 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 decentralized automated medication system maintains the integrity of the information in the system and protects patient confidentiality; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The decentralized 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:</text>
    <paragraph num="(1)">
      <text>The pharmacist reviews the order within 24 hours of removal from the decentralized automated medication system; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The prescriber reviews the patient medical history and authorizes the administration of the dose to the patient.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Decentralized automated medication systems shall operate in a manner which:</text>
    <paragraph num="(1)">
      <text>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 medications 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 decentralized automated medication system.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The requirements listed in §C(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="E.">
    <text>A permit holder shall indicate on the initial, renewal, and reinstatement applications:</text>
    <paragraph num="(1)">
      <text>Whether the permit holder operates a decentralized 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>