Oklahoma Administrative Code
Title 535 - Oklahoma State Board of Pharmacy
Chapter 15 - Pharmacies
Subchapter 6 - Hospital Drug Room
Section 535:15-6-5 - Drug room and PIC responsibilities and duties
Universal Citation: OK Admin Code 535:15-6-5
Current through Vol. 42, No. 1, September 16, 2024
(a) Responsibilities. Responsibilities of the hospital drug room and PIC include drug purchasing, acquisition, preparation, distribution, monitoring, security, storage and control.
(1)
Written procedures.
The hospital drug room and PIC shall establish written procedures for the safe
and efficient acquisition, distribution, and utilization of all medicine
products with any of the Federal legends such as "RX only" and medications
administered or distributed in the hospital system. A current copy of such
procedures shall be available for review by the Board.
(2)
General Responsibility. The
hospital drug room and PIC shall be responsible for the safe and efficient
monitoring, distribution, control, purchasing, acquisition and accountability
of all drugs including but not limited to Federal legend drug products used in
diagnostic procedures, I.V. fluids, or contained in supply kits excluding blood
bank products and reagents controlled by the laboratory. The other professional
staff of the hospital facility shall cooperate with the pharmacist in meeting
this responsibility.
(3)
Confidentiality. The hospital drug room and PIC shall have
responsibility for establishing policies for the security and integrity of any
patient information, confidential and non-confidential, and must abide by all
relevant State and Federal regulations applicable to the hospital
system.
(4)
Adverse Drug
Events Program. The hospital drug room and PIC shall develop and
maintain a program to monitor the actual and potential adverse drug events
including pharmacist interventions, medication errors, and adverse drug
reactions for all medications utilized in the hospital to include system wide
programs if an integrated system is involved. Records indicating the tracking,
review, and outcome of the Adverse Drug Events shall be kept current and
available for Board inspection.
(5)
Investigational drug programs. The PIC shall establish a policy
for investigational drug use.
(6)
Review of medication orders. The PIC shall cause medication orders
to be reviewed by a 100 pharmacist in a timely manner.
(7)
Pharmacists Visits. The
hospital drug room and PIC shall cause and document a minimum of 52 routine
in-house visits per year to be made to a hospital with a drug room as required
by health department rule OAC
310:667-21-2(a)
et seq.
(A) No more than 2 visits in any
7-day period shall be counted towards this minimum.
(B) No more than 5 visits in any one month
count toward the 52 visit total for the year.
(C) Visits in any calendar month shall be no
less than 2.
(D) The PIC shall
submit a report outlining issues encountered and decisions made during visits.
A copy of this report shall be available in the hospital drug room for
inspection by the Board.
(E) A
licensed hospital drug room employing a full-time pharmacist is not required to
document the 52 routine in-house visits since daily work is done, interventions
are documented, and audit systems are maintained.
(8)
Pharmacy and Therapeutics (P&T)
Committee. The PIC shall be a participating member in the Pharmacy and
Therapeutics Committee.
(9)
Effective Controls. The hospital drug room and PIC shall establish
and maintain effective controls against the diversion of prescription drugs
into other than legitimate medical, scientific, or industrial channels as
provided by federal, state or local laws or rules.
(b) Duties. The duties of a PIC in a licensed hospital drug room, at a minimum, shall be the following:
(1) The training duties of the PIC are:
(A) Competency training regarding preparation
and sterilization of sterile compounded preparations prepared by appropriate
hospital staff;
(B) Competency
training of personnel concerning medicine incompatibilities and providing
incompatibility information; and
(C) Training personnel in confidentiality of
protected health and proprietary information and regarding the compliance with
all federal and state laws and regulations applicable to the hospital drug
room.
(i) Such rules regarding
confidentiality of patient records are described in
535:15-3-14(e),
the federal HIPAA regulations; and,
(ii) Such responsibilities for
confidentiality shall be as set forth in
535:10-3-1.1(6)
and
535:10-3-1.2(a)
(16) and the rules of this Title.
(D) Conducting initial and continuing
competency training of all drug room personnel.
(2) Repackaging drug products including unit
dose.
(3) Establishing procedures
for procurement of all medicines used within the hospital system subject to
approval of the medical and professional staff.
(4) Participating in the development and
maintenance of a formulary for use within the hospital system.
(5) Maintaining and making available a
sufficient inventory of medicines including antidotes and other emergency drugs
approved by the medical and professional staff, for use within the hospital
facility. In addition, current references, antidote information, and telephone
numbers of regional reference centers such as Poison Centers and Drug
Information Centers shall be maintained and readily available throughout the
hospital.
(6) Maintaining oversight
of the records of all transactions of the drug room required by applicable
local, state, and federal law, and necessary to maintain accurate control and
accountability for all medications.
(7) Participating in those aspects of the
hospital facility's patient care evaluation programs that relate to medicine
utilization and effectiveness.
(8)
Cooperating fully with teaching and/or research programs in the hospital
facility, if any.
(9) Implementing
the policies and decisions of the appropriate committees of the medical and
professional staff that deal with drug distribution.
(10) Meeting all inspection and other
requirements of the Oklahoma Pharmacy Act, and those rules and regulations
governing the practice of pharmacy within a hospital facility.
(11) Establishing guidelines for the safe and
effective distribution of medicines intended for floor stock, and their
subsequent administration.
Added at 20 Ok Reg 2479, eff 1-1-04; Amended at 27 Ok Reg 2249, eff 7-11-10
Disclaimer: These regulations may not be the most recent version. Oklahoma may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.