Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This amendment removes geographic
restrictions on remote data entry sites and allows Missouri licensed or
registered pharmacy technicians and intern pharmacists to perform remote data
entry from a site located in a U.S. state or territory.
(1) Definitions.
(A) "Remote Data Entry Sites"-A remote site
located in a U.S. state or territory that is operated by a Missouri licensed
pharmacy and used by a Missouri licensed or registered pharmacy technician or
intern pharmacist to electronically perform non-dispensing data entry
functions, including, but not limited to, obtaining, entering, validating, or
processing patient information or data.
(B) "Supervising Pharmacy"-A Missouri
licensed pharmacy that is physically located in Missouri and responsible for
operating a remote data entry site.
(2) Licensing.
(A) "Remote Data Entry Sites"-A permit is not
required for a remote data entry site. The site shall be deemed part of and
operating under the supervising pharmacy's permit. The supervising pharmacy
must maintain an address listing of all remote data entry sites in operation
which must be made immediately available upon request of the board or the
board's authorized designee.
(3) Remote data entry sites must be safely
operated in compliance with applicable state and federal law. The supervising
pharmacy is responsible for all pharmacy operations at the remote data entry
site. No medication or medical device may be located at or dispensed from a
remote data entry site.
(A) Adequate security
and supervision must be maintained at all times to prevent unauthorized access
to the remote data entry site and equipment. Confidential records must be
securely maintained to prevent unauthorized access to, and unauthorized
storage/transfer of, confidential information. Any breach in the security of
the remote data entry site equipment or confidential records must be documented
and reported to the board in writing within seven (7) days of the breach. Paper
patient or prescription records may not be generated, located, or maintained at
a remote data entry site.
(B)
Except as otherwise provided by state and federal requirements, the remote data
entry site and the supervising pharmacy must share a common database or
prescription record-keeping system that allows real-time, online access to
relevant patient profile information by both the supervising pharmacy and the
remote site. The identity of the pharmacy technician or intern pharmacist
responsible for remotely entering, validating, or modifying data at a remote
data entry site must be electronically documented/recorded in the pharmacy's
records and maintained for a minimum of five (5) years.
(C) Pharmacy technicians and intern
pharmacists operating at a remote data entry site must be competent in the
duties performed. At a minimum, technicians and intern pharmacists must have
completed employer approved training in the activities performed remotely and
must have an initial and, if applicable, annual documented assessment of
competency. Documentation of the completed training and competency assessment
must be maintained in the pharmacy's records for a minimum of two (2) years and
provided to the board or the board's designee upon request;
(D) A sufficient mechanism must be in place
to allow communication between the supervising pharmacist and pharmacy
technician or intern pharmacist when needed. A pharmacist must be available to
respond to technician/intern pharmacist questions at all times a remote data
entry site is in operation and must provide the personal assistance, direction,
and approval required to verify and ensure delegated tasks are safely and
properly performed. Non-dispensing data entry functions may not be performed by
a pharmacy technician or intern pharmacist at a remote data entry site if the
required real-time communication mechanism is not operating or
available.
(E) Remote data entry
sites may be inspected by the board as authorized by law. Notification by the
inspector will be provided to the supervising pharmacy a minimum of seventy-two
(72) hours ahead of the scheduled inspection. The supervising pharmacy permit
holder must arrange for a designated representative to be present that is not a
resident of the location under inspection.
(4) Policies and Procedures. The supervising
pharmacy must establish written policies and procedures governing all aspects
of operation of a remote data entry site that are reviewed annually by the
pharmacist-in-charge. At a minimum, policies and procedures must include
authorized technician and intern pharmacist activities, site security
procedures and requirements, reporting security breaches, quality assurance
review procedures, and staff education/training. The annual policy and
procedure review date must be documented in the pharmacy's
records.
