Ohio Administrative Code|Rule 4729:5-22-03 | Record keeping.

                                                

(A) A non-limited facility 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) of rule 4729:5-22-02 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 drug were personally furnished, the
positive identification of the prescriber or delegated pharmacist 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 and 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
4729:5-22-03 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, 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 to the records; and

(4) Contains daily
back-up functionality to protect against record loss.

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