Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule establishes standards for
pharmacists providing prescription services to residents in long-term care
facilities. The standards are directed to licensed pharmacists and pharmacies,
and not to long-term care facilities.
PUBLISHER'S NOTE: The secretary of state has
determined that the publication of the entire text of the material which is
incorporated by reference as a portion of this rule would be unduly cumbersome
or expensive. Therefore, the material which is so incorporated is on file with
the agency who filed this rule, and with the Office of the Secretary of State.
Any interested person may view this material at either agency's headquarters or
the same will be made available at the Office of the Secretary of State at a
cost not to exceed actual cost of copy reproduction. The entire text of the
rule is printed here. This note refers only to the incorporated by reference
material.
(1) Licensure. A
pharmacist who or pharmacy which provides prescription services to a long-term
care facility must be licensed to practice pharmacy in this state. A long-term
care facility means a nursing home, retirement care, mental care or other
facility or institution which provides extended health care to resident
patients.
(2) Medication Services.
(A) Policies and procedures shall be
formulated to cover all packaging and dispensing responsibilities of the
pharmacist/pharmacy to the residents of the long-term care facility and shall
include, at a minimum:
1. Methods used to
dispense medications in a timely fashion to the facility;
2. Proper notification to the facility when a
medication is not readily available;
3. Proper labeling requirements to meet the
needs of the facility and which are consistent with state and federal laws;
and
4. Appropriate medication
destruction, return of unused medication, or both, which is consistent with
state and federal laws.
(B) Container labeling, at all times, shall
conform to Chapter 338, RSMo. If a label change is required to reflect a change
in directions, the pharmacist personally shall affix the correct label to the
container. However, direction change labels which are defined as indicator
labels that notify long-term care facility personnel that a change in
directions for medication has taken place, may be used and affixed to the
container by nursing home personnel in a way as not to deface the original
label. Labeling of unit dose packages may be distinguished from the
requirements as set forth in section
338.059,
RSMo by insuring that the drug name and strength, control number and expiration
date and manufacturer's name appear on the package itself. A patient's name and
directions may not have to appear directly on the medication container but a
mechanism should exist to identify for the personnel administering medications,
what medications each patient is to receive and the directions for
administration.
(C) All
prescription containers, including, but not limited to, single unit, unit dose
and unit-of-use containers utilized for distribution within a long-term care
facility shall meet minimum requirements as referenced by the United
States Pharmacopoeia (USP) which is incorporated herein by reference.
Where applicable, light-sensitive packaging shall be used.
(3) Any drug, repackaged or prepacked that is
dispensed into a long-term care facility, as defined in section (1) of this
rule, in other than the manufacturer's original container, shall bear the
manufacturer's expiration date or twelve (12) months, whichever is
less.
(4) Remote dispensing systems
are defined as any system of an automated or manual design that is used to
provide doses of medication to patients for the immediate administration by
authorized health care personnel and is not licensed under Chapter 338, RSMo as
a pharmacy. Any medication obtained in excessive amounts shall constitute the
practice of pharmacy and will require adherence to all applicable licensure and
drug laws.
(A) If personnel other than a
pharmacist restocks a remote dispensing system, then any drugs or other items
that are to be placed within a remote dispensing system must be checked and
approved by a licensed pharmacist.
(B) Any products that are repackaged for use
in a remote dispensing system must comply with all provisions of 4 CSR
220-2.130.
(C) Appropriate security
must be maintained over any remote dispensing system and there must be policies
and procedures utilized in the delivery and storage of drugs and devices that
deter misuse or theft.
(5) A prescription drug order is defined for
the purpose of this rule as an order originating from a long-term care facility
that is initiated by a prescriber and entered into the patient's medical record
by the prescriber or qualified personnel for the purpose of initiating or
renewing an order for a medication or device. All prescription drug orders
shall comply with 4 CSR 220-2.018.
(A) A
prescription drug order may be transferred to a licensed pharmacy for the
purpose of providing an order to prepare, compound or dispense a medication or
for the purpose of providing drug or medical information for use by the
pharmacist in providing patient care services.
(B) In order for a generic substitution as
defined in section
338.056,
RSMo to take place, a prescription drug order must either comply with the
prescription form as defined in section 338.056.2(1), RSMo or provide an
alternate method for documenting whether a generic substitution has been
authorized as determined by the long-term care medical staff. When a generic
substitution is authorized and is executed by the pharmacist a clear
documentation must be completed in accordance with 4 CSR 220-2.018(1)(H) and 4
CSR 220-2.080(2)(M).
(C) A pharmacy
may elect to maintain a separate file system for prescription drug orders that
are dispensed. When a separate file is utilized, it must comply with all
applicable laws governing the maintenance and use of a prescription file by a
pharmacy and the numbering system used to number prescription drug orders must
be distinct from any other prescription file that is maintained.
(D) Packaging and labeling of containers
shall comply with all applicable state and federal laws for any medications
that leave the facility or are provided to the patient by the pharmacy for use
outside the facility. Prescription drug orders issued for use within the
long-term care facility are not valid for refill outside the
facility.
(6) Nothing in
this rule shall be deemed to constitute a waiver or abrogation of any of the
provisions of Chapter 338, RSMo or other applicable provisions of state and
federal laws and rules, nor should this rule be construed as authorizing or
permitting any person not licensed as a pharmacist to engage in the practice of
pharmacy.
(7) The provisions of
this rule are declared severable. If any portion of this rule is held invalid
by a court of competent jurisdiction, the remaining provisions of this rule
shall remain in full force and effect unless otherwise determined by the
court.
*Original authority: 338.010, RSMo 1939, amended 1951,
1989, 1990; 338.140, RSMo 1939, amended 1981, 1989, 1997; 338.210, RSMo 1951;
338.240, RSMo 1951; and 338.280, RSMo 1951, amended 1971,
1981.
