<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".07" citation="COMAR 10.34.41.07" title_num="10" subtitle_num="34" chapter_num="41" heading="Standard Procedures.">
  <paragraph num="A.">
    <text>Before a pharmacist administers a maintenance injectable medication, a pharmacist shall have and maintain a written procedure for any maintenance injectable medication that may be administered.</text>
  </paragraph>
  <paragraph num="B.">
    <text>A pharmacist shall administer a maintenance injectable medication in accordance with the written procedure, including:</text>
    <paragraph num="(1)">
      <text>Recording and maintaining the prescription files in accordance with Regulation .05 of this chapter;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Reviewing and screening for the following:</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="(3)">
      <text>Reviewing the 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;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Following injection or administration procedures;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Advising the patient of post-administration procedures, including waiting requirements; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Documenting and maintaining a maintenance injectable medication record, including:</text>
      <paragraph num="(a)">
        <text>Patient’s:</text>
        <paragraph num="(i)">
          <text>Name;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Date of birth;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Address;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Consent form;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Authorized prescriber; and</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Administering pharmacist’s name and license number;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>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>Maintenance injectable medication:</text>
        <paragraph num="(i)">
          <text>Name, generic or brand;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Manufacturer;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Lot number; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Expiration date;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>Notification to the authorized prescriber that the patient received a specific maintenance injectable medication; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Verification that the prescription is:</text>
        <paragraph num="(i)">
          <text>Not for the patient’s initial dose, if applicable; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>For the patient’s initial dose and the patient’s record contains documented approval from the authorized prescriber.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The pharmacist shall:</text>
    <paragraph num="(1)">
      <text>Sign and date the standard procedure at least annually;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Make the standard procedure available for inspection by the Board upon request; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Review and update the standard procedure as necessary.</text>
    </paragraph>
  </paragraph>
</regulation>