Current through Register Vol. 54, No. 12, March 23, 2024
(a) This section establishes standards
applicable to licensed pharmacies that utilize automated medication systems
which may be used to store, package, dispense or distribute
prescriptions.
(b) A pharmacy may
use an automated medication system to fill prescriptions or medication orders
provided that:
(1) The pharmacist manager, or
the pharmacist under contract with a long-term care facility responsible for
the dispensing of medications if an automated medication system is utilized at
a location which does not have a pharmacy onsite, is responsible for the
supervision of the operation of the system.
(2) The automated medication system has been
tested and validated by the pharmacy and found to dispense accurately prior to
the implementation of the system. The pharmacy shall make the results of the
testing available to the Board upon request.
(3) The pharmacy shall make the automated
medication system available to the Board for the purpose of inspection, whereby
the Board may validate the accuracy of the system.
(4) The automated medication system must
electronically record the activity of each pharmacist, technician or other
authorized personnel with the time, date and initials or other identifier so
that a clear, readily retrievable audit trail is established. A pharmacist will
be held responsible for transactions performed by that pharmacist or under the
supervision of that pharmacist.
(c) The pharmacist manager or the pharmacist
under contract with a long-term care facility responsible for the delivery of
medications shall be responsible for the following:
(1) Reviewing and approving all policies and
procedures for system operation, safety, security, accuracy, access and patient
confidentiality.
(2) Ensuring that
medications in the automated medication system are inspected, at least monthly,
for expiration date, misbranding and physical integrity, and ensuring that the
automated medication system is inspected, at least monthly, for security and
accountability.
(3) Assigning,
discontinuing or changing personnel access to the automated medication
system.
(4) Ensuring that the
automated medication system is stocked accurately and an accountability record
is maintained in accordance with the written policies and procedures of
operation.
(5) Ensuring compliance
with the applicable provisions of State and Federal law.
(d) When an automated medication system is
used to fill prescriptions or medication orders, it shall be operated according
to written policies and procedures of operation created or adopted by the
pharmacy. The policies and procedures of operation must:
(1) Include a table of contents.
(2) Include a description of all procedures
of operation.
(3) Set forth methods
that ensure retention of each amendment, addition, deletion or other change to
the policies and procedures of operation for at least 2 years after the change
is made. Each change shall be signed or initialed by the registered pharmacist
manager and include the date on which the registered pharmacist manager
approved the change.
(4) Set forth
methods that ensure that a pharmacist currently licensed in the transmitting
jurisdiction reviews and approves the transmission of each original or new
prescription or medication order to the automated medication system before the
transmission is made.
(5) Set forth
methods that ensure that access to the records of medications and other medical
information of the patients maintained by the pharmacy is limited to licensed
practitioners or personnel approved to have access to the records.
(6) Set forth methods that ensure that access
to the automated medication system for stocking and removal of medications is
limited to licensed pharmacists or the pharmacist's designee acting under the
supervision of a licensed pharmacist. An accountability record which documents
all transactions relative to stocking and removing medications from the
automated medication system must be maintained.
(7) Identify the circumstances under which
medications may be removed from the automated medication system by a licensed
medical practitioner for distribution to a patient without prior order review
by a licensed pharmacist.
(e) A pharmacy that uses an automated
medication system to fill prescriptions or medication orders shall, at least
annually, review its written policies and procedures of operation and revise
them, if necessary.
(f) A copy of
the written policies and procedures of operation adopted under this section
shall be retained at the pharmacy and at the long-term care facility where the
automated medication system is utilized. Upon request, the pharmacy shall
provide to the Board a copy of the written policies and procedures of operation
for inspection and review.
(g) The
pharmacist manager shall be responsible for ensuring that, prior to performing
any services in connection with an automated medication system, all licensed
practitioners and supportive personnel are trained in the pharmacy's standard
operating procedures with regard to automated medication systems set forth in
the written policies and procedures. The training shall be documented and
available for inspection.
(h) A
pharmacy that uses an automated medication system to fill prescriptions or
medication orders shall create and operate according to a written program for
quality assurance of the automated medication system which:
(1) Requires monitoring of the automated
medication system.
(2) Establishes
mechanisms and procedures to test the accuracy of the automated medication
system at least every 6 months and whenever any upgrade or change is made to
the system.
(3) Requires the
pharmacy to maintain all documentation relating to the written program for
quality assurance for at least 2 years. Upon reasonable notice from the Board,
the pharmacy shall provide information to the Board regarding the quality
assurance program for automated medication systems.
(i) A pharmacy that uses an automated
medication system to fill prescriptions or medication orders shall maintain a
written plan for recovery from a disaster that interrupts the ability of the
pharmacy to provide services. The written plan for recovery must include:
(1) Planning and preparation for a
disaster.
(2) Procedures for
response to a disaster.
(3)
Procedures for the maintenance and testing of the written plan for
recovery.
(j) A pharmacy
that uses an automated medication system to fill prescriptions or medication
orders shall maintain a written program for preventative maintenance of the
system. Documentation of completion of all maintenance shall be kept on file in
the pharmacy for at least 2 years.