La. Admin. Code tit. 46 § LIII-1124

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

Section LIII-1124 - Records of Pharmacy Services for Patients in Licensed Healthcare Facilities Other than Hospitals

A. Definitions

Dispensing of a Drug Pursuant to an Inpatient Prescription-Repealed.

Electronic Drug Record Keeping System-a system of storing drug records electronically and capturing the positive identification of the person responsible for a specific drug transaction including, but not limited to, the prescribing, administering, or dispensing of a drug.

Inpatient-a person receiving health care services within a healthcare facility other than a hospital licensed by the department.

Inpatient Prescription-Repealed.

Password-a private identification that is created by a user to obtain access to an electronic drug record keeping system.

Personal Identifier-a unique user name or number for identifying and tracking a specific users access to an electronic drug record keeping system such as Social Security number, user identification number, or employee number

Positive Identification-

a. as the same meaning as defined in Section 1119 of this Chapter, except that a specific facility having a closed electronic drug record keeping system may be permitted to use identifiers utilizing both a password combined with a personal identifier to document the positive identification of each user for the prescribing and administration of a drug, provided the pharmacist-in-charge has determined:

i. adequate audit controls are in place to detect and deter drug diversion;

ii. adequate access controls are in place to assure the identity of the user and to assign accountability of the user for any drug transaction;

iii. adequate safeguards are in place to prevent and detect the unauthorized use of an individuals password and personal identifier;

iv. an ongoing quality assurance program is in place to ensure that Clauses i through iii of this term are being fulfilled and reviewed; and

v. appropriate policies and procedures are in place to address Clauses i through iv of this term;

b. all of the above notwithstanding, however, positive identification as defined in Section 1119 of this Chapter shall always be used to document the:

i. dispensing, compounding, or prepackaging of a drug;

ii. removal and possession of a controlled substance to administer to a patient; and

iii. waste of a controlled substance.

B. Drug Distribution and Control. The pharmacist-in-charge shall be responsible for the safe and efficient procurement, receipt, distribution, control, accountability, and patient administration and management of drugs.

1. Procedure Manual. The pharmacist-in-charge shall maintain defined procedures for the safe and efficient distribution of medications and pharmacy care. A current copy of the manual shall be available for board inspection upon request.

2. Inventories. The pharmacist-in-charge shall be responsible for the performance of an annual inventory of all controlled dangerous substances within his span of control, in compliance with the provisions of Section 2733 of this Part.

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 inpatient 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 inpatient 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 facility shall be maintained in compliance with Section 1123 of this Chapter.

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

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

ii. manufacturers or distributors control number (except for patient-specific sterile compounded preparations);

iii. manufacturers or distributors 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. pharmacys 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 facility 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 facility 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.

La. Admin. Code tit. 46, § LIII-1124

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 40:2255 (November 2014), effective January 1, 2015, Amended by Department of Health, Board of Pharmacy, LR 46582 (4/1/2020), Amended LR 46694 (5/1/2020).

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