La. Admin. Code tit. 46 § LIII-1123

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

Section LIII-1123 - Records

A. There shall be positive identification of the pharmacist, intern, technician, or technician candidate responsible for performing all activities related to the practice of pharmacy including, but not limited to:

1. prescription information entered into the pharmacy information system;

2. prospective drug utilization review;

3. prescription dispensing;

4. administration of immunizations.

B. A pharmacy may use one of the following types of pharmacy information systems.

1. A system that utilizes the original hard copy prescription or chart order to document the initial dispensing, but utilizes a computerized system to dispense refills that does not document the positive identification of the pharmacist responsible for the practice of pharmacy. In order to document positive identification, this system shall require the manual signature or initials of a pharmacist on a hard copy record as specified in Subsection E of this Section.

C. All pharmacy information systems shall be capable of providing immediate retrieval (via display and hard copy printout or other mutually agreeable transfer media) of patient profile information for all prescriptions- drug orders and chart orders dispensed within the previous two years. This information shall include the following minimum data:

1. the original prescription number;

2. date of issuance of the original prescription drug order or chart order by the prescriber;

3. date of dispensing by the pharmacist;

4. full name and address of the patient;

5. full name and address of the prescriber;

6. directions for use;

7. the name, strength, dosage form, and quantity of the drug prescribed;

8. the quantity dispensed if different from the quantity prescribed;

9. the pharmacist responsible for prescription information entered into the computer system, the pharmacist responsible for prospective drug utilization review as defined in Section 515 of this Part, and the pharmacist responsible for dispensing;

10. the total number of refills authorized by the prescriber; and

11. the refill history of the prescription as defined in Subsection D of this Section.

D. The refill history of the prescription record maintained in the pharmacy information system shall include, but is not limited to:

1. the prescription number;

2. the name and strength of the drug dispensed;

3. the date of the refill or partial fill;

4. the quantity dispensed;

5. the pharmacist responsible for prospective drug utilization review as defined in Section 515 of this Part, and the pharmacist responsible for dispensing each refill;

6. the total number of refills or partial fills dispensed to date for that prescription order.

E. The hard copy documentation required pursuant to Paragraph B.1 of this Section shall be provided by each individual pharmacist who makes use of such system by signing a statement attesting to the fact that the prescription information entered into the computer is correct as displayed.

F. Backup Support System

1. The pharmacy information system shall be capable of being reconstructed in the event of an electronic or computer malfunction or unforeseen accident resulting in the destruction of the system or the information contained therein. To prevent the accidental loss of electronic records, an adequate backup system shall be maintained. Backup support systems shall be updated at least once daily.

2. In the event the pharmacy information system experiences down time, a record of all refills dispensed during such time shall be recorded and then entered into the pharmacy information system as soon as it is available for use. During the time the pharmacy information system is not available, prescriptions drug orders and chart orders may only be refilled if, in the professional judgment of the pharmacist, the number of refills authorized by the prescriber has not been exceeded.

G. A pharmacy purging a pharmacy information system of prescription records shall develop a method of recordkeeping capable of providing retrieval (via display, hard copy printout, or other mutually agreeable transfer media) of information for all prescription drug orders or chart orders filled or refilled within the previous two years. This information shall include, at a minimum, the following data:

1. pharmacy name and address;

2. original prescription number;

3. date of issuance of the original prescription drug order or chart order by the prescriber;

4. date of original dispensing by the pharmacist;

5. full name and address of the patient;

6. full name and address of the prescriber;

7. directions for use;

8. name, strength, dosage form, and quantity of the drug prescribed;

9. quantity dispensed if different from the quantity prescribed;

10. total number of refills authorized by the prescriber;

11. total number of refills dispensed to date for that prescription drug order or chart order;

12. date of each refill;

13. name or initials of each individual dispensing pharmacist.

H. A log shall be maintained of all changes made to a prescription record after the prescription has been dispensed. Such log may be accessible to the pharmacist for review, but shall be protected from being altered in any way. At a minimum, the log shall contain the following information:

1. date and time of change;

2. change(s) made;

3. pharmacist making the change.

I. Prescription drug orders and chart orders entered into a pharmacy information system but not dispensed shall meet all of the following requirements:

1. the complete prescription information shall be entered in the computer system;

2. the information shall appear in the patients profile; and

3. there is positive identification, in the pharmacy information system or on the hard copy prescription, of the pharmacist who is responsible for entering the prescription information into the system.

J. With respect to oral prescriptions received in the pharmacy and then transcribed to written form in the pharmacy, or written prescription drug orders or chart orders received by facsimile in the pharmacy, or written prescriptions drug orders or chart orders presented to the pharmacy, a pharmacy may use an electronic imaging system to preserve such prescriptions, but only if:

1. the system is capable of capturing, storing, and reproducing the exact image of a prescription, including the reverse side of the prescription form and its annotations;

2. any notes of clarification of and alterations to a prescription shall identify the author and shall be directly associated with the electronic image of the prescription form;

3. the image of the prescription form and any associated notes of clarification to or alterations to a prescription are retained for a period of not less than two years from the date the prescription is last dispensed;

4. policies and procedures for the use of an electronic imaging system are developed, implemented, reviewed, and available for board inspection; and

5. The prescription is not for a controlled dangerous substance.

K. Filing and Retention of Prescription Forms

1. Written prescription drug order or chart order forms (including transcriptions of verbal prescriptions received in the pharmacy, prescription drug orders or chart orders received by facsimile in the pharmacy, as well as written prescription drug order or chart order forms presented to the pharmacy shall be assembled and stored in prescription number sequence. Prescriptions for controlled dangerous substances listed in Schedule II shall be filed separately from all other prescriptions. Where multiple medications are ordered on a single prescription form and includes one or more controlled dangerous substances listed in Schedule II, then such forms shall be filed with other Schedule II prescriptions. These original hard copy prescription drug order and chart order forms shall be retained in the prescription department for a minimum of two years following the most recent transaction.

2. For those pharmacies utilizing an electronic imaging system as described in Subsection J of this Section, written prescription drug order forms may be disposed of in a manner which protects the confidentiality of protected health information.

3. Prescription drug order and chart order forms received as an electronic image or electronic facsimile directly within the pharmacy information system shall be retained within the information system for a minimum of two years following the most recent transaction. Further, the pharmacy may produce a hard copy of the prescription drug order form but shall not be required to do so merely for recordkeeping purposes.

4. Electronic prescription drug orders and chart orders, those generated electronically by the prescriber, transmitted electronically to the pharmacy, and then received electronically directly into the pharmacy information system, shall be retained within the information system for a minimum of two years following the most recent transaction. The pharmacy may produce a hard copy of the prescription drug order or chart order, but shall not be required to do so merely for recordkeeping purposes.

L.

a. the patients data record, which should consist of, but is not limited to, the following information:

i. full name of the patient for whom the drug is intended;

ii. residential address and telephone number of the patient;

iii. patients date of birth;

iv. patients gender;

v. a list of current patient specific data consisting of at least the following:

(a).known drug related allergies;

(b). previous drug reactions;

(c). history of or active chronic conditions or disease states;

(d). other drugs and nutritional supplements, including nonprescription drugs used on a routine basis, or devices;

vi. the pharmacists comments relevant to the individual patients drug therapy, including any other necessary information unique to the specific patient or drug;

b. The patient's drug therapy record, which shall contain at least the following information for all the prescription drug orders and chart orders that were filled at the pharmacy:

i. name and strength of the drug or device;

ii. prescription number;

iii. quantity dispensed;

iv. date dispensed;

v. name of the prescriber;

vi. directions for use;

c. any information that is given to the pharmacist by the patient or caregiver to complete the patient data record shall be presumed to be accurate, unless there is reasonable cause to believe the information is inaccurate.

M. Exceptions. The provisions of this Section shall not apply to the following.

1. Pharmacies permitted as hospital pharmacies by the board shall comply with the provisions of Chapter 15 of these rules.

2. Other pharmacies providing medications and services to patients within facilities other than hospitals licensed by the department shall comply with the provisions of §1124 of these rules for those activities.

La. Admin. Code tit. 46, § LIII-1123

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 23:1312 (October 1997), amended LR 29:2090 (October 2003), effective January 1, 2004, LR 36:755 (April 2010), Amended LR 29:2090 (October 2003), effective January 1, 2004, LR 36:755 (April 2010), LR 40:2253 (November 2014), effective January 1, 2015, Amended by the Department of Health, Board of Pharmacy, LR 46580 (4/1/2020), Amended LR 471643 (11/1/2021).

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