Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule establishes guidelines for the use
of automated dispensing and storage systems.
(1) Automated dispensing and storage systems
(hereafter referred to as automated system or system) are hereby defined to
include, but are not limited to, mechanical systems that perform operations or
activities, relative to the storage, packaging or dispensing of medications,
and which collect, control, and maintain all transaction information. Such
systems may be used in pharmacies and where a pharmacy permit exists, for
maintaining patient care unit medication inventories or for a patient profile
dispensing system, provided the utilization of such devices is under the
supervision of a pharmacist. A pharmacist is not required to be physically
present at the site of the automated pharmacy system if the system is
supervised electronically by a pharmacist. In order to supervise the system
within an ambulatory care setting, the pharmacist must maintain constant visual
and auditory communication with the site and full control of the automated
system must be maintained by the pharmacist and shall not be delegated to any
other person or entity. Supervision of an automated refill patient self-service
device requires that a pharmacist employed by the pharmacy by which the device
is owned and operated be available at all times during operating hours of the
pharmacy.
(A) Documentation shall be
maintained by the owner/operator of an automated system for the type of
equipment, locations where all systems are located, identification of all
persons accessing the automated system, the identity of persons stocking or
restocking the system and the pharmacist responsible for checking the accuracy
of medications stocked.
(B)
Automated systems that are used within licensed health care facilities shall be
used only in settings that ensure medication orders are reviewed by a
pharmacist in accordance with established policies and procedures and laws
governing the practice of pharmacy. A pharmacist shall control all operations
of the automated system and approve the release of the initial dose of a
prescription drug order. Subsequent doses from an approved prescription drug
order may be removed from the automated system after this initial approval. Any
change made in the prescription drug order shall require a new approval by a
pharmacist to release the drug.
(C)
In ambulatory care settings, a pharmacist must input all information from a
prescription or prescription drug order into the electronic data system
utilized for the initiation of the dispensing of a drug at a remote site and
maintain proper oversight over the entire dispensing process. A pharmacist
shall be accessible at all times to respond to patient's or other health
professionals' inquiries or requests pertaining to drugs dispensed through the
use of the automated pharmacy system. No prescription shall be prepared or
dispensed from a remote automated system unless it is from a prescriber
providing clinical services at the same location. Labeling of drug containers
must be in accordance with section
338.059,
RSMo, and application of labels to containers must occur prior to release of
the prepared prescription drug from the automated system. Labels shall contain
both the name, address and phone number of the supervising pharmacy and the
remote dispensing site.
(D) When
automated systems are located at remote sites the central pharmacy responsible
for the operation and supervision of a remote site must maintain separate and
readily retrievable records of all transactions and prescriptions processed by
each remote automated system. Remote automated sites must provide the name,
address and toll free telephone number of the supervising pharmacy displayed on
the automated dispensing system in a prominent location.
(E) Automated systems shall maintain adequate
security systems and procedures to prevent unauthorized access or use and shall
at all times maintain compliance with all state and federal drug laws including
all controlled substance requirements and patient confidentiality laws.
1. Any remote automated system that stocks
controlled substances must maintain a perpetual inventory from each
site.
2. Automated systems in
ambulatory care settings must be located in an area that will provide adequate
space for private consultations to occur and must only be installed within the
same area utilized by the prescriber for the provision of clinical
services.
3. Automated refill
patient self-service devices must be physically attached to the pharmacy so
that access to areas used to restock the device are only accessible through the
pharmacy physical plant by pharmacy personnel.
(F) Restocking of automated systems shall be
done by registered technicians under the supervision of a pharmacist or by a
pharmacist.
(G) All events
involving access to the contents of the automated system must be recorded
electronically.
(H) No medication
or device shall be returned directly to the system for reissue or reuse by a
person not licensed or registered by the board of pharmacy.
(I) Quality assurance documentation for the
use and performance of the automated systems shall be maintained for a minimum
period of two (2) years and shall include at a minimum the following:
1. Breach of security of the automated
system;
2. Failure of the system to
operate correctly along with the frequency of any failures and the necessary
repairs completed;
3. Tests
completed to measure the effectiveness and accuracy of the system. every six
(6) months and whenever any upgrade or change is made to the system.
(J) Drugs that are repackaged for
use in automated systems at remote locations must comply with
20 CSR
2220-2.130 Drug Repackaging requirements. Automated
refill patient self-service devices must comply with all labeling and
dispensing laws governing the provision of medication refills to patients.
Products that are considered temperature sensitive or products that require
further manipulation in order to be ready for use by a patient shall not be
provided through patient self-service devices, unless the device has the
capability to provide storage conditions in compliance with Food and Drug
Administration (FDA) requirements.
(K) If an automated system uses removable
cartridges or containers to hold drugs, the prepackaging of the cartridges or
containers must occur at the pharmacy where the original inventory is
maintained unless provided by a FDA approved repackager and who is licensed as
a drug distributor. The prepackaged cartridges or containers may be sent to the
automated system at remote locations to be loaded into the machine by
registered technicians under the supervision of a pharmacist or by a pharmacist
provided that-
1. A pharmacist has verified
the container has been properly filled and labeled;
2. The individual containers are transported
to the automated system in a secure, tamper-evident container; and
3. The automated system utilizes technologies
to ensure that the containers are accurately loaded in the automated
system.
(L) Any pharmacy
that maintains an automated system for remote dispensing to ambulatory patients
must maintain a video camera and audio system to provide for effective
communication between pharmacy personnel and consumers. It must be a system
that will allow for the appropriate exchange of oral as well as written
communications to facilitate patient counseling as provided in
20 CSR
2220-2.190 and other matters involved in the correct
transaction or provision of drugs.
1. Video
monitors used for the proper identification and communication with persons
receiving prescription drugs shall be a minimum of twelve inches (12") wide and
provided at both the pharmacy and remote location for direct visual contact
between pharmacist and patient.
2.
Both the video monitor and the audio system must be in good working order or
operations utilizing the automated system shall cease until appropriate
corrections or repairs are made to the system(s).
3. Backlighting or other factors that may
inhibit video or audio performance must be taken into account when using such
systems to identify recipients of prescription drugs. Positive identification
of recipients must be made before any drug is delivered.
(2) Each automated system shall
maintain a manual of policies and procedures that, at a minimum, shall include
the following:
(A) System operations that
include specific and measurable accountability for safety, security, accuracy,
patient confidentiality, access, data retention and retrieval, downtime
procedures, emergency first dose or refill patient self-service procedures,
inspection of systems by pharmacy personnel, installation requirements,
maintenance, medication security, quality assurance, inventory levels and
control, staff education and training and system set-up and
malfunction.
(B) Documentation by
the automated system at remote locations for on-site patient administration and
remote dispensing of medications that includes specific identification of
patients, medications used along with dates and times the system is
utilized.
(C) Effective procedures
for securing and accounting for wasted medications or discarded
medications.
(D) Access to and
limits on access (security levels) to the automated system must be defined and
must comply with applicable state and federal laws and regulations.
(3) The pharmacist-in-charge is
responsible for the overall compliance of the automated system in the same
manner as other pharmacy operations as outlined in 4 CSR 220-2.090. In
addition, responsibilities will also include:
(A) Establishment of a quality assurance
program prior to implementation of an automated system and the supervision of
an ongoing quality assurance program that monitors appropriate use and
performance of the automated system, which is evidenced by written policies and
procedures developed by the pharmacy;
(B) Assign, discontinue or change access to
the automated system;
(C) Assure
that the automated system is in good working order and accurately provides the
correct strength, dosage form and quantity of a drug prescribed while
maintaining appropriate record keeping and security safeguards.
(D) Procedures used for notifying the board
on a timely basis and other state and federal agencies, when warranted, of any
breach of security which results in the unauthorized removal of
drugs.
(4) Except where
otherwise noted in this rule, all records specified must be retained as a part
of the dispensing record of the pharmacy and in accordance with section
338.100,
RSMo and board regulations governing the proper maintenance and retrieval of
records.
(5) Pharmacies that
maintain automated sites for dispensing drugs to ambulatory patients shall
maintain a Class J: Shared Service classification on each pharmacy permit
involved in such activity.
(6) The
supervising pharmacy shall have sufficient pharmacists on duty such that each
pharmacist may supervise no more than three (3) remote sites that are
simultaneously open to provide services. An exception to the supervision limit
may be granted by the board in situations where the provider has documented a
need for a pharmacist to supervise additional remote sites and has demonstrated
that appropriate safeguards are in place to assure proper supervision of each
remote site.
*Original authority: 338.140, RSMo 1939, amended 1981,
1989, 1997; 338.210, RSMo 1951, amended 2001; 338.220, RSMo 1951, amended 1969,
1981, 1989, 1997, 1999, 2001, 2004; and 338.280, RSMo 1951, amended 1971,
1981.
