<?xml version='1.0' encoding='utf-8'?>
<section article="ghg" article_name="Health - General" number="21-2A-04" title_number="21" title_name="Food, Drugs, and Cosmetics" subtitle_number="2A" subtitle_name="Prescription Drug Monitoring Program">
  <level label="a">
    <text>The Secretary, in consultation with the Board, shall adopt regulations to carry out this subtitle.</text>
  </level>
  <level label="b">
    <text>The regulations adopted by the Secretary shall:</text>
    <level label="1">
      <text>Specify the prescription monitoring data and naloxone medication data required to be submitted under § 21–2A–03 of this subtitle;</text>
    </level>
    <level label="2">
      <text>Specify the electronic or other means by which information is to be submitted:</text>
      <level label="i">
        <text>Without unduly increasing the workload and expense on dispensers; and</text>
      </level>
      <level label="ii">
        <text>In a manner as compatible as possible with existing data submission practices of dispensers;</text>
      </level>
    </level>
    <level label="3">
      <text>Specify that the information be submitted by dispensers once every 24 hours;</text>
    </level>
    <level label="4">
      <text>Specify that the Program:</text>
      <level label="i">
        <text>Shall provide the information technology software to dispensers necessary to upload prescription drug monitoring data and naloxone medication data to the Program; and</text>
      </level>
      <level label="ii">
        <text>May not impose any fees or other assessments on prescribers or dispensers to support the operation of the Program;</text>
      </level>
    </level>
    <level label="5">
      <text>Identify the mechanism by which:</text>
      <level label="i">
        <text>Prescription monitoring data are disclosed to a person, in accordance with § 21–2A–06 of this subtitle; and</text>
      </level>
      <level label="ii">
        <text>Naloxone medication data are disclosed to a person, in accordance with § 21–2A–06.1 of this subtitle;</text>
      </level>
    </level>
    <level label="6">
      <text>Identify the circumstances under which a person may disclose prescription monitoring data or naloxone medication data received under the Program;</text>
    </level>
    <level label="7">
      <text>Specify the process for the Program’s review of prescription monitoring data and naloxone medication data and reporting of:</text>
      <level label="i">
        <text>Possible misuse or abuse of a monitored prescription drug under § 21–2A–06(c) of this subtitle; or</text>
      </level>
      <level label="ii">
        <text>A possible violation of law or possible breach of professional standards under § 21–2A–06(d) of this subtitle;</text>
      </level>
    </level>
    <level label="8">
      <text>Establish requirements for Program retention of prescription monitoring data and naloxone medication data; and</text>
    </level>
    <level label="9">
      <text>Require that:</text>
      <level label="i">
        <text>Confidential or privileged patient information be kept confidential; and</text>
      </level>
      <level label="ii">
        <text>Records or information protected by a privilege between a health care provider and a patient, or otherwise required by law to be held confidential, be filed in a manner that, except as otherwise provided in §§ 21–2A–06 and 21–2A–06.1 of this subtitle, does not disclose the identity of the person protected.</text>
      </level>
    </level>
  </level>
</section>
