<?xml version='1.0' encoding='utf-8'?>
<chapter num="03" heading="Guidelines for Co-Prescribing Opioid Overdose Reversal Drugs" title_num="10" subtitle_num="13">
  <regulation prefix="Regulation" num=".01" heading="Scope.">
    <text>This chapter applies to all licensed health care practitioners who may prescribe an opioid overdose reversal drug to an individual who:</text>
    <paragraph num="A.">
      <text>May be at an elevated risk of experiencing an opioid overdose including, but not limited to, an individual who:</text>
      <paragraph num="(1)">
        <text>Is receiving an opioid for chronic pain;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Is receiving an opioid and a prescription for a benzodiazepine; or</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Has an opioid use disorder; or</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Resides or spends time with an individual who:</text>
      <paragraph num="(1)">
        <text>Is prescribed opioids;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Misuses opioids; or</text>
      </paragraph>
      <paragraph num="(3)">
        <text>Has an opioid use disorder.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Definitions.">
    <paragraph num="A.">
      <text>In this chapter, the following terms have the meanings indicated.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Terms Defined.</text>
      <paragraph num="(1)">
        <text>“Co–prescribed” means, with respect to an opioid overdose reversal drug, the practice of prescribing the drug in conjunction with an opioid prescription for a patient at an elevated risk of overdose.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Department” means the Maryland Department of Health.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>“Monitored prescription drug” means a prescription drug that contains a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance designated under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Opioid overdose reversal drug” means a drug that:</text>
        <paragraph num="(a)">
          <text>Rapidly reverses the respiratory depressant effects of an opioid medication; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Is approved by the federal Food and Drug Administration for the treatment of a known or suspected opioid overdose.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(5)">
        <text>“Prescribing licensed health care provider” means an individual who is authorized by law to prescribe a monitored prescription drug.</text>
      </paragraph>
      <paragraph num="(6)">
        <text>“Risk factor” means a characteristic, condition, behavior, or any variable that increases the likelihood of developing a disease or injury.</text>
      </paragraph>
      <paragraph num="(7)">
        <text>“Secretary” means the Secretary of the Maryland Department of Health.</text>
      </paragraph>
      <paragraph num="(8)">
        <text>Targeted Patient Population.</text>
        <paragraph num="(a)">
          <text>“Targeted patient population” means an individual likely to experience or witness an opioid overdose.</text>
        </paragraph>
        <paragraph num="(b)">
          <text>“Targeted patient population” includes, but is not limited to, an individual who:</text>
          <paragraph num="(i)">
            <text>Is being prescribed opioids for acute, if appropriate, or chronic pain;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Is being treated for an opioid use disorder;</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>Is receiving a prescription for an opioid and a benzodiazepine; or</text>
          </paragraph>
          <paragraph num="(iv)">
            <text>Resides or spends time with an individual who is prescribed opioids, misuses opioids, or has an opioid use disorder.</text>
          </paragraph>
        </paragraph>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="General Provisions.">
    <paragraph num="A.">
      <text>When determined appropriate by the prescribing licensed health care provider, targeted patient populations may be co-prescribed an opioid overdose reversal drug, if the individual is at an elevated risk of experiencing an opioid overdose by virtue of belonging to one or more categories of the targeted patient population.</text>
    </paragraph>
    <paragraph num="B.">
      <text>Responsibilities of the Prescribing Licensed Health Care Provider.</text>
      <paragraph num="(1)">
        <text>Risk Monitoring.</text>
        <paragraph num="(a)">
          <text>It is suggested that the licensed health care provider routinely assess patients for their risk of being likely to experience or witness an opioid overdose.</text>
        </paragraph>
        <paragraph num="(b)">
          <text>The prescriber may utilize additional sources of information for determining a patient’s opioid overdose risk including, but not limited to:</text>
          <paragraph num="(i)">
            <text>Checking the Maryland Prescription Drug Monitoring Program;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Reviewing medical records; and</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>Soliciting family input, if appropriate.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Education. If a patient is assessed to be at risk of an opioid overdose, the prescriber may educate the patient about, including but not limited to, the following areas:</text>
        <paragraph num="(a)">
          <text>The risks of an opioid overdose; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>How to identify and respond to an opioid overdose.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>Documentation. Licensed health care providers should document education and clinical services related to the provision of an opioid overdose reversal drug in their patients’ medical records in accordance with the standard of care.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Additional Guidelines.">
    <text>The Secretary may make the following additional clinical guidance available on the Department’s website:</text>
    <paragraph num="A.">
      <text>Any available opioid overdose reversal drug formulations, corresponding prescribing templates, and any standing order for these drugs; and</text>
    </paragraph>
    <paragraph num="B.">
      <text>Any other applicable information deemed necessary by the Secretary.</text>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Health-General Article, §§2-104(b), 13-3501, and 13-3502, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: June 17, 2019 (46:12 Md. R. 544)</annotation>
  </annotations>
</chapter>