Current through Register Vol. 51, No. 19, September 20, 2024
A. A remote
automated medication system may only be used if:
(1) Records concerning transactions or
operations are maintained in accordance with Regulation .11 of this
chapter;
(2) A responsible
pharmacist has been designated by the permit holder to supervise and manage the
operations of the remote automated medication system;
(3) Except for starter doses, a licensed
pharmacist reviews each order for medication:
(a) After the order has been entered into the
system; and
(b) Before the system
permits access to the medication;
(4) The permit holder ensures that:
(a) Patients have prompt access to pharmacy
services necessary for the provision of good pharmaceutical care as defined in
Health Occupations Article, §12-101, Annotated
Code of Maryland;
(b) The remote
automated medication system maintains the integrity of the information in the
system and protects patient confidentiality; and
(c) The remote automated medication system is
subject to a quality assurance program in accordance with Regulation .10 of
this chapter; and
(5) It
is designed to distribute medications in a licensed health care facility, a
related institution as defined in Health-General Article, §19-301,
Annotated Code of Maryland, or a medical facility owned and operated by a group
model health maintenance organization as defined in Health-General Article,
§19-713.6, Annotated Code of Maryland.
B. A starter dose, or a dose in response to
an emergency, may be distributed without prior review by a pharmacist of the
order if the pharmacist reviews the order within 24 hours of removal from the
remote automated medication system.
C. If a licensed pharmacist is not physically
present where the remote automated medication system is located, the pharmacist
shall have access to the system by electronic and visual means in order to
ensure the safe and efficient operation of the system.
D. Remote automated medication systems shall
operate in a manner which:
(1) Unless
packaging and labeling for a specific patient, limits simultaneous access to
multiple:
(a) Drug strengths;
(b) Dosage forms; or
(c) Drug entities;
(2) Prevents access to medication not ordered
for the patient; and
(3) Safeguards
against the misidentification of medications, dosages, and dosage forms by
those accessing the remote automated medication system.
E. The requirements listed in §D(1) and
(2) of this regulation do not apply to automated supply towers which contain:
(1) Noncontrolled medications that are:
(a) Refrigerated;
(b) Bulk; or
(c) Intravenous fluids; or
(2) Prescription
devices.
F. A remote
automated medication system may be used only if the system:
(1) Uses positive drug identification, such
as bar code technology, to ensure accuracy in:
(a) Loading and selection of medications in
the pharmacy for stocking and replenishment of the remote automated medication
system; and
(b) Loading medications
into the remote automated medication system where it is located;
(2) Has electronic reporting
capability regarding the identity of persons with access to the system and
regarding medications removed from the system;
(3) Restricts access to medications to a
licensed pharmacist or an individual authorized to administer medication under
Health Occupation Article, Annotated Code of Maryland; and
(4) Before administration of a medication to
a patient, provides:
(a) A picture of the
medication, if available; or
(b) If
a picture is not available, a written description of the medication
specifically by color, shape, and unique manufacturer markings.
G. The permit holder
shall ensure that the health care facility where the remote automated
medication system is located provides, at a minimum:
(1) A licensed pharmacist available for
consultation 24 hours per day;
(2)
Technical assistance regarding operation of the system available 24 hours per
day; and
(3) A quality assurance
program as set forth in Regulation .10 of this chapter.
H. A permit holder shall indicate on the
initial, renewal, and reinstatement applications:
(1) Whether the permit holder operated a
remote automated medication system; and
(2) Any other information regarding the
system that the Board considers necessary to determine compliance with this
chapter.
