Current through all regulations passed and filed through September 16, 2024
(A)
An OTP 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 (L)(1) of rule
4729:5-21-03 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, delegated
pharmacist, or delegated nurse 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.
(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, 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
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; and
(4)
Contains daily
back-up functionality to protect against record loss.
