Ohio Admin. Code 4729:5-9-03.3 - Record keeping in an institutional facility
This rule applies to records for dangerous drugs, including those dispensed by an institutional pharmacy to inpatients, maintained in areas outside of the institutional pharmacy by an institutional facility.
(A)
An institutional facility shall maintain a record of
all dangerous drugs administered to patients that includes all the following
information:
(1)
Name of the patient;
(2)
Name, strength,
dosage form, route of administration, and quantity of the dangerous drugs
administered;
(3)
Date and time the dangerous drugs were
administered;
(4)
The positive identification of the person removing the
dangerous drug for patient administration;
(5)
Positive
identification of the personnel administering the drug; and
(6)
For controlled
substance dangerous drugs:
(a)
If removed from a secured location, the positive
identification of the person removing the controlled substance for patient
administration; and
(b)
The disposal of an unused portion of a controlled
substance conducted in accordance with paragraph (J) of rule
4729:5-9-03.2 of the
Administrative Code.
(B)
Records of
dangerous drugs personally furnished at an institutional facility 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 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.
(C)
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.
(D)
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.
(E)
Records of
temperature control monitoring described in paragraph (F) of rule
4729:5-9-03.2 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.
(F)
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, the positive
identification of the licensed health care professional that performed the
disposal.
(G)
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 dangerous
drugs shall be documented using positive identification. All orders for drugs
for inpatients shall include the following:
(1)
Name of
patient;
(2)
Name, strength, and dosage form of
drug;
(3)
Directions for use, including route of
administration;
(4)
Date prescribed; and
(5)
The ordering
prescriber's positive identification.
(H)
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.
(I)
Controlled substance inventory records shall be maintained
in accordance with rule
4729:5-3-07 of the
Administrative Code.
(J)
All records required in accordance with this chapter
shall be maintained under appropriate supervision and control to restrict
unauthorized access.
(K)
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.
(L)
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.
Replaces: 4729-17-04
Notes
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.09, 4729.28, 4729.51
Prior Effective Dates: 09/01/1985, 07/01/1991, 01/10/1996, 02/01/1998, 03/01/1999, 01/01/2006, 01/01/2009
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