SECTION 535:15-6-7. Drug distribution and control

(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. The other professional staff of the hospital facility shall cooperate with the PIC in meeting this responsibility. The PIC shall be responsible for, at a minimum, the following:

(1)   Competency education and training of nursing personnel concerning admixture of sterile compounded preparations, and incompatibility and provision of proper incompatibility information.

(2)   Prepackaging and/or preparing of drug products including certification of unit dose.

(3)   Establishing of specifications for procurement of all materials including drugs, chemicals, and biologicals used within the hospital system, subject to approval of the appropriate committee of the hospital system.

(4)   Participating in the development and maintenance of a formulary for use within the hospital facility.

(5)   Maintaining and making available a sufficient inventory of medicines, including antidotes and other emergency drugs, 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)   Reviewing records of all transactions of the hospital drug room required by applicable local, state, and federal law, necessary to maintain accurate control and accountability for all medicine materials.

(7)   Participating in those aspects of the hospital facility's patient care evaluation programs that relate to drug utilization and effectiveness.

(8)   Developing a mechanism to implement the policies and decisions of the appropriate committees of the hospital that deal with drug distribution and drug utilization.

(9)   Meeting all inspection and other requirements of the Act, and those rules and regulations applying to hospital drug rooms.

(10)   Establishing floor stock guidelines for the safe and effective distribution of drugs intended for floor stock, and their subsequent administration.

(11)   Fully cooperating with teaching and/or research programs in the hospital facility, if any.

(12)   Prepackaging medications included in the hospital drug room formulary in 535:15-6-9.

(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 discharged 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 with a distinctive supplementary label whether within or outside the direct and 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 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.

[Source: Added at 20 Ok Reg 2479, eff 1-1-04; Amended at 32 Ok Reg 1229, eff 8-27-15]