Okla. Admin. Code § 535:15-5-10

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

Section 535:15-5-10 - Director of Pharmacy responsibilities

(a)Written procedures.The Director of Pharmacy shall establish written procedures for the safe and efficient acquisition, distribution, storage, and utilization of pharmaceutical products with any of the federal legends such as "Rx Only" and medications administered or used in the hospital system. Such procedures shall be annually reviewed and a current copy shall be on hand for Board inspection.

(b)General responsibilities.The Director of Pharmacy shall be responsible for the safe and efficient purchasing, acquisition, monitoring, distribution, control, security, 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. The other professional staff of the hospital facility shall cooperate with the Director in meeting this responsibility. The Director shall be responsible for, at a minimum, the following:

(1) Preparing and sterilizing sterile compounded preparations prepared within the hospital facility.

(2) Admixing sterile compounded preparations including education and training of nursing personnel concerning incompatibility and provision of proper incompatibility information when the admixture of sterile compounded preparations is not accomplished within the hospital pharmacy.

(3) Preparing drug products including unit dose.

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

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

(6) Filling and dispensing all drugs which are to be administered within the hospital facility.

(7) Maintaining and making available a sufficient inventory of pharmaceuticals, 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.

(8) Maintaining records of all transactions of the hospital pharmacy required by applicable local, state, and federal law, and necessary to maintain accurate control and accountability for all pharmaceutical materials.

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

(10) Cooperating fully with teaching and/or research programs in the hospital facility, if any.

(11) Implementing the policies and decisions of the appropriate committees of the hospital, which deal with drug distribution and drug utilization.

(12) Meeting all inspection and other requirements of the Act, and the rules and regulations governing the practice of pharmacy within a hospital facility.

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

(14) Initial and continuing training of pharmacy technicians.

(c)Confidentiality.The Director of Pharmacy shall have direct responsibility for the security and integrity of any patient pharmacy information, confidential and non-confidential, and must comply with all federal and state laws and regulations applicable to the hospital pharmacy.

(1) Rules regarding confidentiality of patient records are described in 535:15-3-14(e); and,

(2) 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)Adverse Drug Events program.The Director of Pharmacy 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.

(1) Policies indicating the tracking, review, and outcome of the adverse drug events shall be kept current and available for Board inspection.

(2) Sentinel events, direct impact findings, and root cause analyses involving drugs and/or Medication Management Standards of The Joint Commission shall be maintained and be available for Board inspection.

(e)Investigational drug programs.The Director of Pharmacy shall maintain a file for review by the Board of all investigational drug protocols open and closed that have been approved by the hospital Investigational Review Board.

(f)Discontinued drug orders.The Director of Pharmacy shall develop and implement policies and procedures to insure that discontinued drugs, outdated drugs, and containers with worn, illegible or missing labels are returned to the pharmacy for proper disposition.

(g)Controlled drug accountability.The hospital facility shall maintain adequate records regarding the use and accountability of controlled substances and such other drugs as the hospital may designate; and as directed by the Oklahoma State Bureau of Narcotics and the Federal Drug Enforcement Administration. The Director of Pharmacy shall establish effective written procedures to implement this requirement.

(h)Drug recall procedures.The Director of Pharmacy shall develop and implement a written recall procedure that can be readily activated which assures that drugs involved, inside or outside of the facility, are returned to the pharmacy for proper disposition. All actions taken in this area are to be properly documented and maintained for 36 months for Board review.

(i)Records and reports.The Director of Pharmacy shall maintain and submit, 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) Inventory listing of the pharmacy.

(4) Controlled substance inventory.

(5) Ethyl alcohol inventory.

(6) Pharmacy and therapeutic committee minutes.

(7) Reports and records as required by law and/or rules.

(8) Outpatient prescriptions shall contain all information required by pharmacy law and rule.

(j)Pharmacist staffing.The Director of Pharmacy shall maintain adequate staffing levels of pharmacists to insure pharmaceutical patient-focused care support. This staffing shall be a sufficient number of additional licensed pharmacists as may be required to operate such a pharmacy competently, safely and adequately to meet the needs of the patients of the hospital facility as to meet requirements described in 535:15-5-4.

(k)Automated dispensing systems.The Director of Pharmacy shall maintain control to insure that direct pharmacist intervention and responsibility (and certification of medication order) is present and consistent in any cycle of automated dispensing from acquisition of product through the terminal dispensing act prior to administration to the patient of any medication as described in these rules.

(1) The Board must be provided with prior written notice of the installation or removal, or major upgrade that physically changes the operation of automated dispensing systems.

(2) Such notice must include, but is not limited to the:

(A) name and address of the pharmacy;

(B) location of the automated equipment;

(C) identification of the pharmacist-in-charge; and

(D) name of manufacturer and model of system;

(3) Along with such notice, submit a copy of the automated dispensing system quality assurance plan to the Board for review.

(4) The terminal act of automated dispensing must be to a licensed caregiver (nurse, prescriber, or person authorized by law to administer the drug not intended to include medication technicians or CMAs) in the hospital facility in no more than a 24-hour supply of medication that has been reviewed by a pharmacist.

Okla. Admin. Code § 535:15-5-10

Amended at 9 Ok Reg 2141, eff 6-11-92; Amended at 10 Ok Reg 3171, eff 6-25-93; Amended at 18 Ok Reg 2738, eff 7-1-01; Amended 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.