Current through all regulations passed and filed through September 16, 2024
(A)
An institutional
pharmacy shall document, using positive identification, the licensed or
registered individuals responsible for performing the following activities
authorized under Chapter 4729. of the Revised Code and agency 4729 of the
Administrative Code:
(1)
Medication order or prescription information entered
into the record keeping system. This provision shall take effect one-year from
the effective date of this rule.
(2)
Verification by
the pharmacist of the prescription information entered into the record keeping
system.
(3)
Drug utilization review in accordance with rule
4729:5-9-02.6 of the
Administrative Code, which shall be captured as a standalone action or as part
of either:
(a)
The pharmacist verification of prescription information as
required by paragraph (A)(2) of this rule; or
(b)
The dispensing
process in paragraph (A)(4) of this rule.
(4)
Dispensing,
except that a pharmacist shall not be required to perform a check of dangerous
drugs prior to distribution if the drug is dispensed in accordance with
either:
(a)
Paragraph (F)(5) of this rule; or
(b)
In accordance
with rule
4729:5-3-17 of the
Administrative Code.
(5)
Compounding in
accordance with Chapter 4729:7-2 of the Administrative Code.
(6)
Administering
immunizations pursuant to section
4729.41 of the Revised
Code.
(7)
Administering other injectable drugs pursuant to
section 4729.44 of the Revised
Code.
(8)
Prescription information transcribed from an order
received by telephone or recording device.
(9)
Any changes or
annotations made to a prescription or medication order.
(B)
An
institutional pharmacy shall maintain the following records:
(1)
All medication
orders issued in accordance with rule
4729:5-9-02.7 of the
Administrative Code.
(2)
Records of drugs dispensed shall including all the
following:
(a)
The name, strength, dosage form, route of administration, and quantity of drugs
dispensed;
(b)
The date of dispensing;
(c)
The name of the
inpatient to whom, or for whose use, the drug was dispensed;
and
(d)
The positive identification of the individuals involved
in the dispensing process in accordance with paragraph (A)(1) of this
rule.
(C)
An institutional pharmacy shall maintain records of all
drugs dispensed to outpatients pursuant to rule
4729:5-5-04 of the
Administrative Code.
(D)
An institutional pharmacy shall maintain records of all
drugs repackaged pursuant to rule
4729:5-9-02.12 of the
Administrative Code.
(E)
An institutional pharmacy shall maintain records of all
drugs compounded pursuant to Chapter 4729:7-2 of the Administrative
Code.
(F)
An institutional pharmacy shall maintain records for
the distribution of non-patient specific dangerous drugs to other areas of the
institutional facility for administration or use, which shall include all the
following:
(1)
The name, strength, dosage form, and amount of drug
distributed.
(2)
The area receiving the drug.
(3)
The date
distributed.
(4)
Except as provided in paragraph (F)(5) of this rule,
the positive identification of the pharmacist checking the dangerous drugs
prior to distribution. Such documentation shall be maintained for a period of
three years in a manner that is readily retrievable.
(5)
A pharmacist
shall not be required to perform a check of dangerous drugs prior to
distribution if all the following apply:
(a)
The drugs are
distributed in accordance with paragraph (A)(2)(a) of rule
4729:5-3-17 of the
Administrative Code.
(b)
The drugs are stored or will be stored in an automated
drug storage system that utilizes barcode system to track and correctly
identify drugs stored within the system.
(c)
A pharmacist has
conducted an initial check of every barcode to ensure they have been assigned
correctly to the appropriate drug. The initial check shall be documented using
positive identification and maintained for a period of three years in a manner
that is readily retrievable.
(d)
The pharmacy
develops and implements a policy that includes all the following:
(i)
Verification by a
pharmacist, documented using positive identification, prior to any changes to
barcodes, additions to the formulary, or modification of a drug's national drug
code (NDC). Any change shall be documented using positive identification and
maintained for a period of three years in a manner that is readily
retrievable.
(ii)
Requiring a pharmacist to document using positive
identification the addition of auxiliary barcodes to drugs. Such documentation
shall be maintained for a period of three years in a manner that is readily
retrievable.
(iii)
A process to immediately alert the pharmacy of an error
resulting from an incorrect barcode or a barcode override to ensure the
accuracy of the system.
(iv)
Prohibits a pharmacy technician or pharmacy intern from
moving or modifying any barcodes inside the system. Any modifications may only
be done by a pharmacist and shall be documented using positive identification.
Such documentation shall be maintained for a period of three years in a manner
that is readily retrievable.
(6)
For
non-controlled dangerous drugs: the identification of the facility personnel
receiving the drug or authorized personnel stocking the automated drug storage
system.
(7)
For controlled substance dangerous drugs: the positive
identification of the facility personnel receiving the drug or authorized
personnel stocking the automated drug storage system.
(G)
Records of receipt of dangerous drugs shall contain the name, strength, dosage
form, and quantity of the dangerous drugs received, the name and address of the
seller, the name and address of the recipient, and the date of
receipt.
(H)
Records of temperature control monitoring described in
paragraph (D) of rule
4729:5-9-02.2 of the
Administrative Code shall include any of the following:
(1)
For temperature
logs, either:
(a)
The date and time of observation, the full name or the
initials of the individual performing the check, and the temperature recorded;
or
(b)
For systems that provide automated temperature
monitoring, maintain a report that provides, at a minimum, the date and time of
observation and the temperature recorded.
(2)
For temperature
monitoring systems capable of detecting and alerting staff of a temperature
excursion, maintain reports that provide information on any temperature
excursion that includes the date, time, temperature recorded, and length of
each excursion.
(I)
Records of dangerous drugs disposed from inventory,
other than controlled substances, shall contain the name, strength, dosage
form, and quantity of the dangerous drug disposed, the date of disposal, the
method of disposal, and, if disposal is performed on-site, the positive
identification of the licensed health care professional that performed the
disposal.
(J)
Records of controlled substance drug disposal shall
comply with the requirements of rule
4729:5-3-01 of the
Administrative Code.
(1)
If the disposal of controlled substance drug inventory
is performed on-site in an institutional pharmacy, records shall also include
the positive identification of two licensed or registered healthcare
professionals conducting and witnessing the disposal, one of whom shall be a
pharmacist.
(2)
If conducting the disposal of an unused portion of a
controlled substance resulting from administration to a patient in an
institutional pharmacy, records shall also include the positive identification
of two licensed or registered healthcare professionals conducting and
witnessing the disposal.
(K)
Controlled
substance inventory records shall be maintained in accordance with rule
4729:5-3-07 of the
Administrative Code.
(L)
Records of transfers to other terminal distributors of
dangerous drugs, including sales conducted in accordance with rule
4729:5-3-09 of the
Administrative Code, shall contain the name, strength, dosage form, and
quantity of the dangerous drug transferred, the address of the location where
the drugs were transferred and the date of transfer.
(M)
All institutional
pharmacy records required in accordance with this chapter shall be maintained
under appropriate supervision and control to restrict unauthorized
access.
(N)
All institutional pharmacy records maintained in
accordance with this chapter shall be uniformly maintained for a period of
three years. Except as provided in paragraph (N)(3) of this rule, all records
shall be made readily retrievable.
(1)
Computerized drug record keeping systems or subsequent
storage of such records, must be retrievable via digital display, hard copy
printout, or other mutually agreeable transfer medium.
(2)
If a computerized
drug record keeping system is being utilized, the method(s) of achieving
positive identification must be approved, in a manner determined by the board,
prior to implementation or any subsequent modification.
(3)
Record keeping
systems shall provide immediate retrieval via digital display and hard copy
printout or other mutually agreeable transfer medium of information for all
prescriptions, or medication orders, dispensed within the previous twelve
months, and shall provide in a manner that is readily retrievable information
on all prescriptions dispensed beyond the previous twelve months but within the
previous three years.
(4)
All computerized record keeping systems shall be able
to capture records edited by authorized personnel and maintain an audit trail
as defined in rule
4729:5-9-01 of the
Administrative Code.
(5)
All paper records maintained electronically shall be
scanned in full color via technology designed to capture information in one
form and reproduce it in an electronic medium presentable and usable to an end
user.
(6)
All computerized record keeping systems, including
systems used to store scanned paper records, shall have daily back-up
functionality to protect against record loss and security features to prevent
unauthorized access.
(O)
(1)
Except as provided for in paragraph (O)(2) of this
rule, all records maintained in accordance with this chapter shall be
maintained on-site.
(2)
An institutional pharmacy located in this state
intending to maintain records at a location other than the location licensed by
the state board of pharmacy shall send a request in a manner determined by the
board. The board will provide written or electronic notification to the
institutional pharmacy documenting the approval or denial of the request. A
copy of the board's approval shall be maintained at the licensed location. Any
such alternate location used to store records shall be secured and accessible
only to authorized representatives or contractors of the terminal distributor
of dangerous drugs.
Replaces: 4729-17-05
