Current through Vol. 42, No. 1, September 16, 2024
(a)
General. The PIC shall establish written procedures for the safe
and efficient distribution of medicine products. A copy of such procedures
shall be on hand for inspection by the Board.
(b)
Responsibility. The PIC
shall be responsible for the safe and efficient distribution, control, and
accountability of drugs, see
535:15-6-5(b).
(c)
Labeling. Hospital drug room
labeling requirements shall be as follows:
(1)
Labeling for use inside the
hospital facility. All drugs outside of the drug room intended for use
within the facility shall be adequately labeled by the pharmacist or in their
original container.
(2)
Labeling for use outside the hospital facility. All drugs labeled
by the pharmacist or licensed practitioner for after-hours dispensing to
discharge or emergency room patients shall be labeled with the following:
(A) Name and address of the hospital
facility,
(B) Date and identifying
number,
(C) Name of the
patient,
(D) Directions for use to
the patient,
(E) Name of the
prescriber,
(F) Initials of the
dispenser,
(G) Required
precautionary information regarding controlled substances,
(H) Such other accessory or cautionary
information as may be required or desirable for proper use and safety to the
patient, and
(I) the name of the
drug, its strength, and the number of units dispensed.
(3)
Sterile compounded
admixtures. When any drugs are added to sterile solutions or
suspensions, such admixtures shall be labeled whether within or outside the
direct personal supervision of a pharmacist. This label shall indicate the name
and amount of the drug added, date and time of such addition, expiration date
and time of admixture, and the initials of the persons (preparer and the
verifier) responsible for the admixture.
(d)
Discontinued and outdated
drugs. The PIC shall develop and implement policies and procedures to
insure that discontinued and outdated drugs, and containers with worn,
illegible or missing labels are returned to the drug room for proper
disposition.
(e)
Prescriber's
orders. Hospital drug room requirement regarding prescriber's orders
shall be as follows:
(1) Drugs may be
dispensed to specific patients only upon the written or verbal order of an
authorized prescriber. A pharmacist or other authorized individual in a patient
care area of the hospital facility must commit verbal prescriber's orders to
writing.
(A)
Authorization. The
appropriate hospital committee shall designate those prescriber's authorized to
issue and accept orders for hospital patients.
(B)
Requirements. Orders for
drugs for use by inpatients of the facility shall, at a minimum, contain the
patient's name and room number, drug name, strength, directions for use, any
relevant stop date or time, order date and time, and prescriber's signature. A
copy of the order is to be provided to the drug room from which the order is to
be processed.
(2) Orders
for drugs for outpatients shall be considered prescriptions and must fulfill
all of the requirements of a prescription identified within the Pharmacy
Practice Act, and state and federal law and rules.
(f)
Controlled drug
accountability. The hospital facility shall establish effective written
procedures and maintain adequate records as required by law and rule regarding
the use and accountability of controlled substances and such other drugs as the
hospital may designate.
(g)
Drug recall procedures. The PIC shall develop and implement a
written recall procedure that can be readily activated which assures that drugs
involved, inside or outside the facility, are returned to the hospital drug
room for proper disposition. All actions taken in this area are to be properly
documented.
(h)
Records and
reports. The PIC shall develop a mechanism for maintaining and
submitting as appropriate, such records and reports as are required to insure
patient health, safety, and welfare. These should include the following:
(1) Adverse drug reaction reports,
(2) Floor stock inventories of night cabinets
and emergency boxes,
(3) Drug list
or formulary of the hospital drug room as required by state health department
rules,
(4) Controlled substance
inventory,
(5) Ethyl alcohol
inventory,
(6) Pharmacy and
therapeutics committee minutes; and
(7) Reports and records as may be required by
law, and the rules of this chapter.
Added at 20 Ok Reg 2479,
eff 1-1-04
