La. Admin. Code tit. 46 § LIII-1509

Current through Register Vol. 50, No. 9, September 20, 2024

Section LIII-1509 - Drug Distribution Control

A. The hospital pharmacist-in-charge shall be responsible for the safe and efficient procurement, receipt, distribution, control, accountability, and patient administration and management of drugs. The staff of the hospital pharmacy shall cooperate with the pharmacist-in-charge in meeting drug control requirements in ordering, administering, and accounting for pharmaceuticals.

1. Procedure Manual. The pharmacist-in-charge shall maintain written procedures for the safe and efficient distribution of pharmaceutical products and delivery of pharmacy care. An updated copy shall be available for board inspection upon request.

2. Inventories. The pharmacist-in-charge shall:

a. perform an annual inventory on all controlled dangerous substances; and

b. maintain a perpetual inventory of Schedule I and II controlled dangerous substances.

3. Records. The pharmacist-in-charge shall be responsible for maintaining the following records:

a. a record of all drugs procured, the quantity received, and the name, address and wholesale distributor license number of the person from whom the drugs were procured;

b. all drug orders and records relating to the practice of pharmacy:

i. records of drugs dispensed shall include, but are not limited to:

(a). the name, strength, and quantity of drugs dispensed;

(b). the date of dispensing;

(c). the name of the hospital patient to whom, or for whose use, the drug was dispensed; and

(d). positive identification of all pharmacists involved in the dispensing;

ii. all other records relating to the practice of pharmacy other than dispensing shall include, but are not limited to:

(a). the name of the hospital patient to whom, or for whose benefit, the activity was performed;

(b). the nature of the pharmacy practice activity performed;

(c). the results of the activity, if applicable; and

(d). positive identification of all pharmacists involved in the activity; identifying the function performed by each pharmacist;

iii. Records of drugs dispensed to patients for use outside the hospital shall be maintained in compliance with Section 1123 of this Part.

c. a record of all drugs compounded or prepackaged for use only within that hospital, which shall include at least the following:

i. name of drug, strength, quantity, and dosage form;

ii. manufacturer's or distributor's control number (except for patient-specific sterile compounded preparations);

iii. manufacturer's or distributor's name, if a generic drug is used;

iv. pharmacy control number;

v. manufacturer's or distributor's expiration date (except for patient-specific sterile compounded preparations);

vi. pharmacy's expiration date or beyond-use date;

vii. identification of the licensed person responsible for the compounding or prepackaging of the drug;

d. a record of the distribution of drugs to patient care areas and other areas of the hospital held for administration, which shall include at least the following:

i. the name, strength, dosage form, and amount of the drug distributed;

ii. the area receiving the drug;

iii. the date distributed;

iv. identification of the individual receiving the drug if it is a controlled dangerous substance;

v. the area of the hospital receiving the controlled dangerous substance shall make a record of all such drugs administered to patients. Such records shall include at least the following:

(a). name of the patient;

(b). name, dosage form, and strength when applicable of the drug;

(c). date and time the drug was administered;

(d). quantity administered;

(e). positive identification of the personnel administering the drug;

e. a log that shall be maintained of all changes made to a drug record in an electronic drug recordkeeping system after a drug transaction has been made. The log shall contain at least, but is not limited, to the following:

i. date and time of change;

ii. changes made;

iii. person making the change.

B.Automated Medication Systems. A hospital pharmacy may use one or more automated medication systems in compliance with the provisions of Chapter 12 of this Part.

1. When the pharmacy uses an electronic product verification process as described in Section 1217 of this Part, and in the absence of any subsequent human intervention in the automated drug product selection process, the pharmacist-in-charge may elect to forego manual checks of drug products selected in that manner, provided however, that such selection by the pharmacist-in-charge shall require an initial quality assurance validation followed by an ongoing quality review at intervals no greater than 90 days since the previous review, all conducted by a pharmacist.

2. The pharmacist-in-charge remains accountable to the board for the accuracy of all drug distribution activities.

La. Admin. Code tit. 46, § LIII-1509

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2093 (October 2003), effective January 1, 2004, Amended LR 40:2257 (November 2014), effective January 1, 2015, Amended by LR 41:1488 (8/1/2015), Amended by Department of Health, Board of Pharmacy, LR 46583 (4/1/2020).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.