Current through all regulations passed and filed through September 16, 2024
(A)
A clinic or
prescriber office shall keep a record of all dangerous drugs received,
administered, personally furnished, disposed, sold or
transferred.
(B)
Records of receipt 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.
An invoice from a drug distributor licensed in accordance with division 4729:6
of the Administrative Code containing the required information may be used to
meet this requirement.
(C)
Records of temperature control monitoring described in
paragraph (K)(1) of rule
4729:5-19-03 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.
(D)
Records of
personally furnishing shall contain the name, strength, dosage form, and
quantity of the dangerous drugs personally furnished, the name, address and
date of birth of the person to whom or for whose use the dangerous drugs were
personally furnished, the positive identification of the prescriber personally
furnishing the drug, the date the drug is personally furnished and, if
applicable, the date the drug is received by the patient or patient's
caregiver.
(E)
(1)
Records of
administration shall contain the name, strength, dosage form, and quantity of
the dangerous drugs administered, the name and date of birth of the person to
whom or for whose use the dangerous drugs were administered, the date of
administration, and either:
(a)
For non-controlled substance dangerous drugs: the
identification of the health care professional administering the
drug.
(b)
For controlled substance dangerous drugs: the positive
identification of the health care professional administering the
drug.
(2)
Records of dangerous drugs administered which become a
permanent part of the patient's medical record shall be deemed to meet the
requirements of this paragraph.
(3)
Records of
dangerous drugs administered by a health care professional, acting within the
professional's scope of practice, who is not a prescriber shall include
documentation of an order issued by a prescriber or protocol authorizing the
administration of the drug. An order that is a permanent part of the patient's
medical record shall be deemed to meet the requirements of this paragraph.
Orders for the administration of controlled substances shall be documented
using positive identification.
(4)
Paragraph (E)(3)
of this rule does not apply to the administration of dangerous drugs pursuant
to paragraph (G) of rule
4729:5-19-03 of the
Administrative Code or non-controlled dangerous drugs for direct administration
to a patient that have been dispensed by a pharmacy or personally furnished by
a prescriber.
(F)
Records of disposal of dangerous drugs 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 the identification of the licensed health care
professional that performed the disposal.
(G)
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, records shall also include the positive identification of
two licensed healthcare professionals conducting and witnessing the disposal,
one of whom shall be the responsible person or the responsible person's
designee.
(2)
If conducting the disposal of an unused portion of a
controlled substance resulting from administration to a patient or the disposal
of patient owned drug stock maintained in accordance with paragraph (G) of rule
4729:5-19-03 of the
Administrative Code, records shall also include the positive identification of
two licensed healthcare professionals conducting and witnessing the
disposal.
(H)
Records of transfer or sale conducted in accordance
with rule
4729:5-3-09 of the
Administrative Code shall contain the name, strength, dosage form, national
drug code, expiration date and quantity of the dangerous drug transferred or
sold, the address of the location where the drugs were transferred or sold, and
the date of transfer or sale.
(I)
Controlled
substance inventory records shall be maintained in accordance with rule
4729:5-3-07 of the
Administrative Code.
(J)
All records maintained in accordance with this rule and
rule 4729:5-19-03 of the
Administrative Code shall be readily retrievable and shall be kept on-site for
a period of three years.
(1)
A terminal distributor intending to maintain records at
a location other than the location licensed by the state board of pharmacy must
notify the board in a manner determined by the board.
(2)
Any such
alternate location shall be secured and accessible only to authorized
representatives or contractors of the terminal distributor of dangerous
drugs.
(K)
All records maintained pursuant to this rule may be
electronically created and maintained, provided that the system that creates
and maintains the electronic record does so in accordance with the
following:
(1)
Complies with the requirements of this rule;
(2)
All paper records
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;
(3)
Contains security features, such as unique user names
and passwords, to prevent unauthorized access to the records;
and
(4)
Contains daily back-up functionality to protect against
record loss.
