La. Admin. Code tit. 48 § I-9353

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-9353 - Delivery of Services

A. All compounding, packaging, and dispensing of drugs, biologicals, legend and controlled substances shall be accomplished in accordance with Louisiana law and Board of Pharmacy regulations and be performed by or under the direct supervision of a registered pharmacist currently licensed to practice in Louisiana.

B. Dispensing of prescription legend or controlled substance drugs direct to the public or patient by vending machines is prohibited.

C. Current and accurate records shall be maintained on the receipt, distribution and dispensing of all scheduled drugs in such a manner as to facilitate complete accounting for the handling of these controlled substances. An annual inventory, at the same time each year, shall be conducted for all schedule I, II, III, IV and V drugs.

D. A hospital outpatient pharmacy shall maintain all records and inventory separate and apart from that of the inpatient pharmacy, and shall require a separate pharmacy permit to operate.

E. Medications are to be dispensed only upon written or electronic orders, facsimile, or oral orders from a physician or other legally authorized prescriber, and be taken by a qualified professional.

F. All inpatient drug containers shall be labeled to show at least the patient's full name, room number, the chemical or generic drug's name, strength, quantity and date dispensed unless a unit dose system is utilized. Appropriate accessory and cautionary statements as well as the expiration date shall be included. Floor stock containers shall contain the name and strength of the drug, lot and control number or equivalent, and the expiration date. In unit dose systems, each single unit dose package shall contain the name and strength of the drug, lot and control number or equivalent, and expiration date. Outpatient drug containers shall be labeled to show at least the patient's full name, the prescriber's name, the chemical or generic drug's name, directions, name of the pharmacy and pharmacist, prescription number, and appropriate accessory and cautionary statements. Outdated, mislabeled or otherwise unusable drugs and biologicals shall be separated from useable stock, shall not be available for patient or other use and shall be returned to an authorized agency for credit or destroyed according to current state or federal laws as applicable.

G. In accordance with the acceptable, nationally recognized standards of practice and/or guidelines, the medical staff, in coordination and consultation with the pharmacy service, shall determine and establish the reasonable time to automatically stop orders for drugs and biologicals not specifically prescribed as to time or number of doses. The hospital shall implement, monitor, and enforce the automatic stop system.

H. The director of pharmacy shall develop and implement a procedure that in the event of a drug recall, all employees involved with the procurement, storage, prescribing, dispensing and administering of recalled drugs in the facility will be notified to return these drugs to the pharmacy for proper disposition.

I. Drug administration errors, adverse drug reactions, and incompatibilities shall be immediately reported to the attending physician, pharmacist and, if appropriate, to the hospital-wide quality assessment and improvement program. An entry shall be made in the patient's record.

J. Abuses and losses of controlled substances shall be reported to the individual responsible for pharmaceutical services, the chief executive officer, the Louisiana Board of Pharmacy, and to the Regional Drug Enforcement Administration (DEA) office, as appropriate.

K. Information relating to drug interactions, drug therapy, side effects, toxicology, dosage, indications for use and routes of administration shall be available to the staff.

L. A formulary system shall be established by the appropriate hospital committee to assure quality pharmaceuticals at reasonable costs, in accordance with applicable federal and state laws.

M. Naloxone nasal spray, as an over-the-counter (OTC) non-prescription drug, may be distributed by the hospital to patients and/or non-patients who present in the hospital. Other non OTC formulations and dosages of naloxone will remain available by prescription only.

La. Admin. Code tit. 48, § I-9353

Promulgated by the Department of Health and Human Resources, Office of the Secretary, LR 13:246 (April 1987), amended by the Department of Health and Hospitals, Office of the Secretary, Bureau of Health Services Financing, LR 21:177 (February 1995), LR 29:2411 (November 2003), Amended by the Department of Health, Health Standards Section, LR 50, exp. 10/26/2024(Emergency), Amended LR 501279 (9/1/2024), LR 501484 (10/1/2024).

AUTHORITY NOTE: Promulgated in accordance with R.S.36:254 and R.S. 40:2100-2115.