<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".06" citation="COMAR 10.34.32.06" title_num="10" subtitle_num="34" chapter_num="32" heading="Approved Protocols.">
  <paragraph num="A.">
    <text>A pharmacist shall have and maintain a written protocol for any vaccine to be administered, including influenza vaccination.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The pharmacist shall administer vaccinations in accordance with the written protocol.</text>
  </paragraph>
  <paragraph num="C.">
    <text>The written protocol for each vaccine shall contain at least the following elements:</text>
    <paragraph num="(1)">
      <text>Identity and license number of the participating pharmacist;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Vaccine;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Precautions to vaccine use;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Contraindications to vaccine use;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Process to be followed for screening for:</text>
      <paragraph num="(a)">
        <text>Indications;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Precautions;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Contraindications; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Allergies;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>Process for obtaining and documenting consent;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Process for verification of prescription for patients 11—17 years old for vaccinations other than the influenza vaccine;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Dose or doses of the vaccine that will be administered;</text>
    </paragraph>
    <paragraph num="(9)">
      <text>The route or routes and site or sites of administration of the vaccine;</text>
    </paragraph>
    <paragraph num="(10)">
      <text>The injection or administration procedures;</text>
    </paragraph>
    <paragraph num="(11)">
      <text>Post-vaccination procedures, including waiting requirements;</text>
    </paragraph>
    <paragraph num="(12)">
      <text>Process for handling adverse reactions, including but not limited to:</text>
      <paragraph num="(a)">
        <text>Acute anaphylactic reactions; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Other acute emergencies; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(13)">
      <text>Process for documenting and maintaining a vaccination record including at least:</text>
      <paragraph num="(a)">
        <text>Patient:</text>
        <paragraph num="(i)">
          <text>Name;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Date of birth; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Address;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Vaccination administration:</text>
        <paragraph num="(i)">
          <text>Date;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Dose;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Site; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Route;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Vaccine:</text>
        <paragraph num="(i)">
          <text>Manufacturer;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Lot number; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Expiration date;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>Required Vaccine Information Statement:</text>
        <paragraph num="(i)">
          <text>Version; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Provision date;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(e)">
        <text>Name of the patient’s primary care provider or prescriber;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Documentation:</text>
        <paragraph num="(i)">
          <text>Of at least one attempt to inform the patient’s primary care provider or prescriber that the vaccination has been administered; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>That the patient has no primary care provider;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(g)">
        <text>Documentation of an attempt to inform the patient’s primary care provider that the influenza vaccination has been administered may not be required; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>The name of the vaccinator.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The protocol shall be:</text>
    <paragraph num="(1)">
      <text>Signed and dated at least annually by the pharmacist;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Available and presented for inspection to the Board of Pharmacy upon request; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Reviewed and updated as necessary.</text>
    </paragraph>
  </paragraph>
</regulation>