<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".03" citation="COMAR 10.47.07.03" title_num="10" subtitle_num="47" chapter_num="07" heading="Dispenser Reporting.">
  <paragraph num="A.">
    <text>For each monitored prescription drug and naloxone medication dispensed, the dispenser shall report data elements required by American Society for Automation in Pharmacy (ASAP) standards in addition to the following:</text>
    <paragraph num="(1)">
      <text>Identifying information for the prescription issued and drug dispensed, including:</text>
      <paragraph num="(a)">
        <text>Prescription number;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Date prescription was issued;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Date prescription was filled;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Whether the prescription was new or a refill;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Number of refills ordered;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Sources of payment;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>National Drug Code for dispensed drug;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Metric quantity of drug dispensed and units;</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Days’ supply of drug dispensed; and</text>
      </paragraph>
      <paragraph num="(j)">
        <text>Date prescription was sold;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Identifying information for the patient or animal owner or handler, as appropriate, including:</text>
      <paragraph num="(a)">
        <text>Last name;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>First name;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Date of birth;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Gender;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>(text unchanged)</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Address, including residential house or building number, apartment number, street name, state, and zip code;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>A patient identification number, which may include:</text>
        <paragraph num="(i)">
          <text>A state-issued driver’s license or identification card number;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>An insurance or third-party payer identification number;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>A passport identification number;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>An employer-issued identification card number;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>A student identification card number;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>A United States Permanent Resident Card identification number; or</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>A patient or customer identification number generated by the dispenser’s record management system;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(h)">
        <text>ID qualifier; and</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Species indication;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>First and Last name for the prescriber, including:</text>
      <paragraph num="(a)">
        <text>For prescription monitoring data, a valid Drug Enforcement Administration registration number; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>For naloxone medication data, a valid National Provider Identifier;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Identifying information for the dispenser, including a valid Drug Enforcement Administration registration number; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Additional data elements consistent with the standards established by the ASAP.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Reporting Deadline.</text>
    <paragraph num="(1)">
      <text>A dispenser shall report prescription monitoring data and naloxone medication data to the Department to include zero reports at least once every 24 hours and in accordance with procedures developed by the Department and approved by the Advisory Board on Prescription Drug Monitoring.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A dispenser that suffers a mechanical, electrical, or other technical failure that, as a direct consequence, precludes the dispenser’s ability to report prescription monitoring data or naloxone medication data electronically shall:</text>
      <paragraph num="(a)">
        <text>Notify the Department, by a communications method approved by the Department, within 24 hours of discovery of the technical failure; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Submit a report for each monitored prescription drug and naloxone medication dispensed during the period of technical failure as soon as possible, but no later than 24 hours following reestablishment of the means of electronic reporting.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Waiver from Reporting Deadline.</text>
    <paragraph num="(1)">
      <text>At the Secretary’s discretion, a dispenser may be granted a waiver from §B of this regulation, provided that the dispenser’s waiver request:</text>
      <paragraph num="(a)">
        <text>Is submitted on a form or in a method approved by the Department;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Is particular to a unique problem, incident or other issue that prevents the dispenser from meeting the reporting deadline; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Describes in detail and includes any available documentation of the specific circumstances that prevent the dispenser from meeting the reporting deadline.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A dispenser that receives a waiver shall comply with all the terms and conditions enumerated therein, including any new reporting deadline required.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Means of Data Submission and Data Format. Prescription monitoring data shall be transmitted to the Department or its agent:</text>
    <paragraph num="(1)">
      <text>In accordance with any procedures and guidelines established or approved by the Department, including by use of an encrypted electronic transmission method or a secure electronic reporting form; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>In a format or utilizing a data standard approved by the Department.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Reporting of Incomplete or Inaccurate Data. Data not accepted by the Department or its agent due to inaccuracy or incompleteness shall be corrected and resubmitted to the Department no later than 3 business days after receiving notification from the Department of receipt of incomplete or inaccurate data.</text>
  </paragraph>
  <paragraph num="F.">
    <text>Reporting Exemptions. The following shall be exempt from reporting prescription monitoring data to the Program:</text>
    <paragraph num="(1)">
      <text>A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>An opioid treatment service program;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A veterinarian licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland, when prescribing controlled substances for animals in the usual course of providing professional services;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Dispensing to hospice inpatients, provided that the dispensing pharmacy has applied for and been granted a waiver by the Department pursuant to §G of this regulation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>Waiver for Dispensing to Hospice Inpatients.</text>
    <paragraph num="(1)">
      <text>On a form or in a manner approved by the Department, a pharmacy may apply to the Department to be granted a waiver from reporting prescription monitoring data or naloxone medication data for dispensing of monitored prescription drugs to hospice inpatients, provided that:</text>
      <paragraph num="(a)">
        <text>The pharmacy demonstrates, through written application, live demonstration, or any other method required by the Department, how it will distinguish dispensing to hospice inpatients from all other dispensing of monitored prescription drugs required to be reported to the Program; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The pharmacy agrees that it will be subject to unannounced, on-site inspections by the Department to verify its reporting of prescription monitoring data and naloxone medication data on customers that are not hospice inpatients.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A waiver granted to a pharmacy under this regulation shall remain in effect for 2 years.</text>
    </paragraph>
  </paragraph>
</regulation>