<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".26" citation="COMAR 10.07.02.26" title_num="10" subtitle_num="07" chapter_num="02" heading="Pharmaceutical Services.">
  <paragraph num="A.">
    <text>Definition. In this regulation, the term “committee” means the pharmaceutical services committee.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Duties of the Nursing Home.</text>
    <paragraph num="(1)">
      <text>The nursing home shall provide appropriate methods and procedures for administering drugs and biologicals to the nursing home’s residents.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The nursing home shall provide pharmaceutical services in accordance with accepted professional standards and related federal, State, and local laws.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Duties of the Pharmaceutical Services Committee.</text>
    <paragraph num="(1)">
      <text>A pharmaceutical services committee, or its equivalent, shall develop written policies and procedures for safe and effective drug therapy, distribution, control, and use.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The composition of the committee shall include at least:</text>
      <paragraph num="(a)">
        <text>The licensed pharmacist;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The director of nursing;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The consultant dietitian-nutritionist;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>One physician; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>The administrator.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The committee shall meet at least quarterly to establish policies and procedures.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>There shall be an agenda to guide meeting participants.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>All members of the committee shall review revisions of policies and procedures before implementing any changes.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>The pharmaceutical services committee may not develop policies and procedures that prohibit or restrict a resident from receiving medications from the pharmacy of the resident’s choice.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>In cases where the cost of any medication obtained from the pharmacy selected by the resident exceeds the cost of the same or equivalent medication available through a pharmacy that the nursing home has contracted with to provide pharmaceutical services, the resident shall be responsible for the additional amount.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>The committee may not require the pharmacy to provide drugs by way of a specific drug distribution system such as unit dose or use of a particular packaging system.</text>
    </paragraph>
    <paragraph num="(9)">
      <text>The committee shall establish the contents of sealed emergency drug kits.</text>
    </paragraph>
    <paragraph num="(10)">
      <text>The committee shall oversee the accuracy and adequacy of pharmaceutical services to the nursing home.</text>
    </paragraph>
    <paragraph num="(11)">
      <text>The committee shall make recommendations for improvements to pharmaceutical services.</text>
    </paragraph>
    <paragraph num="(12)">
      <text>The committee shall document its actions and recommendations.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Labeling.</text>
    <paragraph num="(1)">
      <text>Medications shall be accurately and plainly labeled. Except for those over-the-counter medications that the Department may list as suitable for purchasing in bulk and dispensing as needed, the labels for all medications shall bear at least:</text>
      <paragraph num="(a)">
        <text>The resident’s full name;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The name of the drug;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Strength;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Original filling date and date refilled, if applicable;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Name of authorized prescriber;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Expiration date of medication (month, year);</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Any special handling and storage instructions;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Name and address of dispensing pharmacy;</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Prescription number;</text>
      </paragraph>
      <paragraph num="(j)">
        <text>Number of tablets or capsules; and</text>
      </paragraph>
      <paragraph num="(k)">
        <text>Accessory federal labels.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>A nurse may not package, repackage, bottle, or label any medication, in whole or in part, or alter any labeled medication in any way.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Storage.</text>
    <paragraph num="(1)">
      <text>The nursing home shall store medications in a locked medication storage area that:</text>
      <paragraph num="(a)">
        <text>Is well lighted;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Is located where personnel preparing drugs for administration will not be interrupted;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Is spacious enough to allow separate storage of external and internal medications;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Is kept in a clean, orderly and uncluttered manner; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Contains a refrigerator to be used for medication storage only.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The nursing home shall keep poisons and medications marked “for external use only” separate from general medications and Schedule II drugs.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Schedule II—IV Drugs.</text>
    <paragraph num="(1)">
      <text>Schedule II drugs shall be kept in separately locked, securely fixed boxes or drawers in the storage area, under two locks. The lock on the door of a medication room shall be counted as one of the two locks.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A nurse and a second staff member who is a nurse or an administrator may destroy controlled dangerous substances in Schedules II—V on the premises of the nursing home.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>If a controlled dangerous substance is destroyed on the nursing home premises in accordance with §F(2) of this regulation:</text>
      <paragraph num="(a)">
        <text>A record of the disposal, in addition to any other required records, shall be maintained in the nursing home; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A copy of the record of disposal shall be forwarded to the Office of Controlled Substances Administration.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>A nursing home, whether or not operating a licensed pharmacy, shall maintain a signed record of a Schedule II count at each change of shift.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A nursing home that administers Schedule II drugs shall maintain a drug record that documents:</text>
      <paragraph num="(a)">
        <text>The name of the resident;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The date, time, kind, dosage, and method of administration of all Schedule II drugs; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>The name of the authorized prescriber who prescribed the medication.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>