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<chapter num="40" heading="Pharmacists Prescribing Contraceptives" title_num="10" subtitle_num="34">
  <regulation prefix="Regulation" num=".01" heading="Scope.">
    <text>This chapter does not limit or otherwise affect the right of an individual to practice pharmacy or any other health occupation that the individual is authorized to practice.</text>
  </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>“Board” means the Maryland Board of Pharmacy.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>“Contraceptives” means contraceptive medications and self-administered contraceptive devices approved by the U.S. Food and Drug Administration.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>“Pharmacist” means an individual who practices pharmacy under the Health Occupations Article, §12-101, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="(4)">
        <text>“Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="(5)">
        <text>“Practicing pharmacy” has the same meaning stated in Health Occupations Article, §12-101(x), Annotated Code of Maryland.</text>
      </paragraph>
      <paragraph num="(6)">
        <text>“Primary care practitioner” means a licensed health care practitioner who:</text>
        <paragraph num="(a)">
          <text>Provides an individual’s primary care services; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Is the primary coordinator of health care services for the individual.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(7)">
        <text>“Reproductive health care practitioner” means a licensed health care practitioner who provides an individual’s reproductive health services.</text>
      </paragraph>
      <paragraph num="(8)">
        <text>“Visit summary” means:</text>
        <paragraph num="(a)">
          <text>A written record of either the contraceptives dispensed or a brief explanation as to why contraceptives were not prescribed;</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Written information about the importance of seeing the patient’s primary care practitioner or reproductive health care practitioner to obtain recommended tests and screenings; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>A copy of the patient’s completed Self-Screening Risk Assessment Questionnaire.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Requirements to Prescribe Contraceptives.">
    <paragraph num="A.">
      <text>Board Responsibilities. The Board shall develop and adopt the following items, in consultation with stakeholders to be determined by the Board:</text>
      <paragraph num="(1)">
        <text>A self-screening risk assessment questionnaire that a patient shall complete before a pharmacist may prescribe contraceptives for a patient;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>A standard procedure contraceptive algorithm which the pharmacist shall use to perform a patient assessment for purposes of determining:</text>
        <paragraph num="(a)">
          <text>Whether to prescribe contraceptives; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Which contraceptive options to prescribe;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>A notification form to be submitted by a pharmacist before prescribing contraceptives; and</text>
      </paragraph>
      <paragraph num="(4)">
        <text>Other forms and procedures for:</text>
        <paragraph num="(a)">
          <text>The prescription of contraceptives; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Referral to a primary care or reproductive health care practitioner for treatment.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>Notification.</text>
      <paragraph num="(1)">
        <text>Except as provided in §B(2) of this regulation, at least 15 days before prescribing contraceptives, a pharmacist shall submit to the Board a notification form, which includes an attestation of completion of a Board-approved training program.</text>
      </paragraph>
      <paragraph num="(2)">
        <text>A pharmacist who has undergone training for prescribing contraceptives as part of the pharmacist’s formal educational program:</text>
        <paragraph num="(a)">
          <text>Is exempt from completing a Board-approved training program; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>At least 15 days before prescribing contraceptives, shall submit to the Board a notification form, which includes an attestation of the pharmacist’s formal education program.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>A pharmacist may not prescribe contraceptives until the pharmacist receives a written confirmation from the Board accepting the pharmacist’s notification form.</text>
      </paragraph>
    </paragraph>
    <paragraph num="C.">
      <text>Pharmacist Responsibilities.</text>
      <paragraph num="(1)">
        <text>For each new patient requesting contraceptive services, and at a minimum of every 12 months for each returning patient, a participating pharmacist shall:</text>
        <paragraph num="(a)">
          <text>Obtain the completed Board-approved self-screening risk assessment questionnaire from the patient; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Utilize and follow the Board-approved standard procedure contraceptive algorithm to:</text>
          <paragraph num="(i)">
            <text>Perform the patient assessment;</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>Determine whether to prescribe contraceptives; and</text>
          </paragraph>
          <paragraph num="(iii)">
            <text>Determine which contraceptive options to prescribe.</text>
          </paragraph>
        </paragraph>
      </paragraph>
      <paragraph num="(2)">
        <text>Upon completion of all requirements established by the Board and after review of all relevant information, a pharmacist may prescribe contraceptives, if deemed clinically appropriate.</text>
      </paragraph>
      <paragraph num="(3)">
        <text>If contraceptives are prescribed, the pharmacist shall:</text>
        <paragraph num="(a)">
          <text>Refer the patient:</text>
          <paragraph num="(i)">
            <text>For additional care to their primary care practitioner or reproductive health care practitioner; or</text>
          </paragraph>
          <paragraph num="(ii)">
            <text>If the patient does not have a primary care practitioner or a reproductive health care practitioner, to a family planning provider or a licensed clinician who provides reproductive health care services;</text>
          </paragraph>
        </paragraph>
        <paragraph num="(b)">
          <text>Provide the patient with a visit summary; and</text>
        </paragraph>
        <paragraph num="(c)">
          <text>Document the encounter and maintain records pursuant to Regulation .05 of this chapter.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(4)">
        <text>Upon completion of all requirements established by the Board and after review of all relevant information, if the pharmacist does not prescribe contraceptives, the pharmacist will provide a visit summary to the patient which provides the basis for the decision not to prescribe contraceptives.</text>
      </paragraph>
      <paragraph num="(5)">
        <text>A pharmacist may not prescribe contraceptives before January 1, 2019.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Training Program Requirements.">
    <text>At a minimum, a Board-approved training program shall contain the following elements:</text>
    <paragraph num="A.">
      <text>An overview of contraceptive medications and self-administered contraceptive devices;</text>
    </paragraph>
    <paragraph num="B.">
      <text>An overview of the self-screening risk assessment questionnaire;</text>
    </paragraph>
    <paragraph num="C.">
      <text>An overview of the standard procedure contraceptive algorithm; and</text>
    </paragraph>
    <paragraph num="D.">
      <text>An overview of the U.S. Medical Eligibility Criteria for Contraceptive Use and other Center for Disease Control guidance on contraception.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Record Keeping.">
    <text>For a minimum of 5 years, a pharmacy whose pharmacists prescribe contraceptives shall maintain documentation, in electronic or other form, which includes:</text>
    <paragraph num="A.">
      <text>The type of contraceptive prescribed, and dosage, if applicable, or the basis for not prescribing a contraceptive;</text>
    </paragraph>
    <paragraph num="B.">
      <text>The name, address, and date of birth of the patient;</text>
    </paragraph>
    <paragraph num="C.">
      <text>The name of the pharmacist who prescribed the contraceptive or determined a contraceptive would not be prescribed;</text>
    </paragraph>
    <paragraph num="D.">
      <text>The date the contraceptive was prescribed or that the patient was advised that a  contraceptive would not be prescribed;</text>
    </paragraph>
    <paragraph num="E.">
      <text>A copy of the patient’s visit summary;</text>
    </paragraph>
    <paragraph num="F.">
      <text>A copy of the patient’s self screening risk assessment questionnaire; and</text>
    </paragraph>
    <paragraph num="G.">
      <text>The name and address of the:</text>
      <paragraph num="(1)">
        <text>Patient’s primary care practitioner or reproductive health care practitioner, if provided by the patient; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Family planning provider or licensed clinician who provides reproductive health care services referred by the pharmacist, if the patient does not have a primary care practitioner or reproductive health care practitioner.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Continuing Education Requirement.">
    <text>A pharmacist who prescribes contraceptives in Maryland shall earn 1 hour of Board-approved continuing pharmaceutical education related to contraception before the pharmacist’s license renewal date.</text>
  </regulation>
  <annotations>
    <annotation type="Authority">Health-Occupations Article, §§12-101, 12-102(b), 12-205(a), and 12-511, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: July 2, 2018 (45:13 Md. R. 668)</annotation>
  </annotations>
</chapter>