Current through all regulations passed and filed through September 16, 2024
(A)
As used in this
rule:
(1)
"Automated pharmacy system" means a mechanical system that
performs operations or activities, other than administration, relative to
storage, packaging, compounding, dispensing, or distribution of dangerous drugs
that collects, controls, and maintains transaction information and
records.
"Automated pharmacy system" does not
include an "automated drug storage system" utilized by institutional facilities
pursuant to Chapter 4729:5-9 of the Administrative Code or other locations
licensed as terminal distributors of dangerous drugs.
(2)
"Dispense" means
the final association of a drug with a particular patient pursuant to a
prescription, drug order, or other lawful order of a prescriber and the
professional judgment of and the responsibility for interpreting, preparing,
compounding, labeling, and packaging a specific drug.
(a)
In the case of an
automated pharmacy system that dispenses dangerous drugs without the final
association by a pharmacist, the system shall capture the positive
identification of the pharmacist authorizing the patientspecific prescription
in the system prior to its dispensation.
(b)
Nothing in this
paragraph shall prohibit an automated pharmacy system from being utilized to
restock an automated drug storage system utilized by institutional facilities
pursuant to Chapter 4729:5-9 of the Administrative Code or other locations
licensed as terminal distributors of dangerous drugs.
(3)
"Positive identification" has the same meaning as in rule
4729:5-5-01 of the
Administrative Code.
(4)
"Tamper evident" means a package, storage container or
other physical barrier that is sealed or secured in such a way that access to
the drugs stored within is not possible without leaving visible proof that such
access has been attempted or made.
(B)
An automated
pharmacy system shall be approved by the board prior to its implementation by
the terminal distributor of dangerous drugs.
(1)
Prior to the
approval of an automated pharmacy system, the board shall receive a request
from the responsible person on the terminal distributor of dangerous drugs
license. Upon notification, the board shall conduct an inspection of the system
to determine if it meets the requirements of this rule.
(2)
For automated
pharmacy systems that dispense dangerous drugs in accordance with paragraph
(A)(2)(a) of this rule, the responsible person of the licensed terminal
distributor of dangerous drugs shall be required to have a pharmacist verify
for accuracy all dangerous drugs dispensed by the system for a continuous
forty-five-day period. The responsible person shall compile metrics, using a
form developed by the board, documenting the performance of the system during
this period. Unless otherwise approved by the board, the accuracy metrics
during the forty-five day pharmacy review period shall be no less than
ninety-nine and nine hundred eighty-five thousandths (99.985) per
cent.
(3)
Approval of all automated pharmacy systems shall be
site-specific.
(C)
An automated pharmacy system shall be located on the
premises of a licensed terminal distributor of dangerous drugs.
(D)
A terminal
distributor of dangerous drugs operating an automated pharmacy system shall
maintain the following documentation on-site in a readily retrievable
manner:
(1)
The
manufacturer's name and model;
(2)
A description of
how the automated pharmacy system is used; and
(3)
Policies and
procedures for system operation, safety, security, accuracy, patient
confidentiality, access, and malfunction.
(E)
All records
maintained in accordance with this rule, including documentation of quality
assurance metrics, shall be readily retrievable and maintained for period of
three years.
(F)
For automated pharmacy systems that dispense dangerous
drugs in accordance with paragraph (A)(2)(a) of this rule, the terminal
distributor of dangerous drugs shall implement a quality assurance program to
determine continued appropriate use of the automated pharmacy system. The
quality assurance program shall monitor the performance of the automated
pharmacy system, ensure the system is in good working order and accurately
prepares the correct strength, dosage form, and quantity of the drug prescribed
or ordered. At a minimum, the quality assurance program shall consist of a
review of at least five per cent of all dispensed prescriptions over the daily
operational hours of the automated pharmacy system.
(G)
If an automated
pharmacy system that dispenses dangerous drugs in accordance with paragraph
(A)(2)(a) of this rule selects an incorrect drug, the terminal distributor
shall immediately institute a one hundred per cent pharmacist verification of
all drugs dispensed. The one hundred per cent verification procedure shall
continue until such time as the terminal distributor can document that the
cause of the error has been determined and addressed and that the system is no
longer making errors.
(H)
A registered or certified pharmacy technician, pharmacy
technician trainee, pharmacy intern, or nurse licensed in accordance with
Chapter 4723. of the Revised Code may stock an automated pharmacy system
provided that:
(1)
Except as provided in paragraph (H)(2) of this rule,
the container, canister, or other dangerous drug storage device being stocked
by the technician, trainee, intern, or nurse is tamper-evident and is verified
by a pharmacist and documented using positive identification.
(2)
Pharmacist
verification requirements in paragraph (H)(1) of this rule do not apply if all
the following are met:
(a)
Verification is being conducted by a registered or
certified pharmacy technician, pharmacy intern, or nurse; and
(b)
The container,
canister, or other dangerous drug storage device being stocked is properly
identified by bar code or other such secondary information system, which has
been verified by a pharmacist to ensure the proper drug is being placed into
and recognized as the correct drug by the system.
(3)
The utilization
of a bar code, electronic verification, or similar verification process shall
require an initial quality assurance validation by a pharmacist and shall be
followed by a quarterly quality assurance review by a
pharmacist.
(4)
The positive identification of the individual stocking
the system is documented.
(5)
A pharmacist is fully responsible for all activities
conducted by the technician, trainee, intern, or nurse.
(6)
A pharmacist must
be immediately available to answer questions or discuss the stocking of an
automated pharmacy system.
(7)
A registered
pharmacy technician or pharmacy technician trainee shall be acting under the
personal supervision of a pharmacist.
(I)
Except for an
automated pharmacy system in a long-term care facility, a pharmacist shall be
physically present at the terminal distributor of dangerous drugs to provide
supervision of the automated pharmacy system.
(J)
The automated
pharmacy system shall have security to prevent unauthorized individuals from
accessing or obtaining dangerous drugs and include safeguards to detect the
diversion of dangerous drugs. This shall include the use of tamper-evident
containers, canisters, or other storage devices for use in long-term care
facilities.
(K)
The records kept by the automated pharmacy system shall
comply with the applicable record keeping requirements of division 4729:5 of
the Administrative Code and shall also capture all events involving the
contents of the automated pharmacy system.
(L)
If applicable, an
automated pharmacy system shall comply with the requirements set forth in
21
CFR 1301.27 (5/13/2005) for automated systems
in long term care facilities.
