<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.34.29.04" title_num="10" subtitle_num="34" chapter_num="29" heading="Requirements for Participation in Drug Therapy Management.">
  <paragraph num="A.">
    <text>In order to enter into a therapy management contract, a pharmacist:</text>
    <paragraph num="(1)">
      <text>Shall be licensed by and in good standing with the Board of Pharmacy;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Shall possess a Doctor of Pharmacy degree or equivalent training as established in §B of this regulation;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>May not have:</text>
      <paragraph num="(a)">
        <text>A public final order by the Board of Pharmacy disciplining the pharmacist's license within the 5 years immediately before the application is submitted; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Limitations placed on the pharmacist's license by the Board of Pharmacy in a public order;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Shall possess relevant advanced training as indicated by one of the following:</text>
      <paragraph num="(a)">
        <text>Certification as a specialist related to the disease state specified by the protocol by:</text>
        <paragraph num="(i)">
          <text>The Board of Pharmacy Specialties;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The American Society of Consultant Pharmacist's Certified Geriatric Practitioner certification program; or</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Another credentialing body approved by the Board of Pharmacy; or</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Successful completion of:</text>
        <paragraph num="(i)">
          <text>A residency accredited by the American Society of Health-Systems Pharmacists, a body approved by the Board of Pharmacy or offered by a body accredited by the Accreditation Council for Pharmacy Education;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>A certificate program approved by the Board of Pharmacy;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>A National Association of Boards of Pharmacy credentialing examination; or</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>An examination approved by the Board of Pharmacy;</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Shall have successfully completed:</text>
      <paragraph num="(a)">
        <text>1,000 hours of relevant clinical experience; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>320 hours in a structured experience program approved by the Board of Pharmacy; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>Shall document training related to the disease state specified in the protocol.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A pharmacist who does not possess a Doctor of Pharmacy degree shall document that the pharmacist's training has included the following components:</text>
    <paragraph num="(1)">
      <text>Designing, implementing, monitoring, evaluating, and modifying or recommending modifications in drug therapy to insure effective, safe, and economical patient care;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Identifying, assessing, and solving medication-related problems, and providing clinical judgments as to the continuing effectiveness of individualized therapeutic plans and intended therapeutic outcomes;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Conducting appropriate physical assessments, evaluating patient problems, and ordering and monitoring medications and laboratory tests in accordance with established standards of practice;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Monitoring patients and patient populations regarding the purposes, uses, effects, and pharmacoeconomics of their medications and related therapy;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Providing emergency first care, including cardiopulmonary resuscitation;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Using clinical data to optimize therapeutic drug regimens; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Documenting interventions and evaluating pharmaceutical care outcomes.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The Board of Pharmacy shall determine whether the pharmacist meets the requirements of §§A and B of this regulation.</text>
  </paragraph>
  <paragraph num="D.">
    <text>An authorized prescriber who has entered into a prescriber-pharmacist agreement shall submit to the Boards that regulate the authorized prescriber a copy of:</text>
    <paragraph num="(1)">
      <text>The prescriber-pharmacist agreement;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Subsequent amendments made to the:</text>
      <paragraph num="(a)">
        <text>Prescriber-pharmacist agreement; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Protocols specified in the prescriber-pharmacist agreement; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Changes to participants of the:</text>
      <paragraph num="(a)">
        <text>Prescriber-pharmacist agreement; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Protocols specified in the prescriber-pharmacist agreement.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>The Boards that regulate the authorized prescriber shall notify the authorized prescriber of any additional information needed within 30 days of the receipt of the submitted information.</text>
  </paragraph>
  <paragraph num="F.">
    <text>A licensed pharmacist who has entered into a prescriber-pharmacist agreement shall submit to the Board of Pharmacy a copy of:</text>
    <paragraph num="(1)">
      <text>The prescriber-pharmacist agreement;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Subsequent amendments made to the:</text>
      <paragraph num="(a)">
        <text>Prescriber-pharmacist agreement; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Protocols specified in the prescriber-pharmacist agreement; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Changes to participants of the:</text>
      <paragraph num="(a)">
        <text>Prescriber-pharmacist agreement; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Protocols specified in the prescriber-pharmacist agreement.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>The Board of Pharmacy shall determine whether a pharmacist added under §F of this regulation meets the requirements of §§A and B of this regulation.</text>
  </paragraph>
  <paragraph num="H.">
    <text>The Board of Pharmacy shall notify the pharmacist of any additional information needed within 30 days of the receipt of the submitted information.</text>
  </paragraph>
</regulation>