Okla. Admin. Code § 535:15-6-5

Current through Vol. 42, No. 4, November 1, 2024

Section 535:15-6-5 - Drug room and PIC responsibilities and duties

(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.

Okla. Admin. Code § 535:15-6-5

Added at 20 Ok Reg 2479, eff 1-1-04; Amended at 27 Ok Reg 2249, eff 7-11-10

Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015.

Amended by Oklahoma Register, Volume 37, Issue 24, September 1, 2020, eff. 9/11/2020