1. (a)

   1. (1) This part shall be construed, if possible, so as not to be in violation of or in conflict with any federal regulation or requirement, and if any part hereof is held invalid because of such conflict, such invalidity shall not affect other provisions or applications of this part that can be given effect without the invalid provisions and to this end, the provisions of this part are declared severable.
   2. (2) In any event, Drug Enforcement Administration permission to use electronic data processing recordkeeping systems must be obtained.
2. (b) The Arkansas State Board of Pharmacy must approve the system prior to implementation.

3. (c)

   1. (1) Input of drug information into the system may be performed only by a pharmacist or by a pharmacy technician under the supervision of a pharmacist.
   2. (2) The final verification of prescription information into the computer shall be made by the supervising pharmacist, who is then totally responsible for all aspects of the data and data entry.
   3. (3) Any judgmental decision concerning patient utilization of drugs must be performed by a pharmacist.
4. (d) The original prescription order must be readily retrievable and filed according to all applicable rules.

5. (e)

   1. (1) An electronic data processing system:

      1. (A) Must be readily retrievable electronically online or by hard copy; and
      2. (B) Shall be capable of printing a hard copy record.
   2. (2) Said hard copy record or electronic database record shall be available upon request by a board representative or other state or federal agencies with authority to obtain such records within forty-eight (48) hours of the request.

   3. (3) The system must be capable of furnishing the following information:

      1. (A)

6. (i) Must provide online retrieval, electronic record or hard copy, of original prescription order information.

   1. (ii) This shall include, but not be limited to, the following:
7. (a) (a) Original prescription order number, date filled, full name and address of patient, and name, address, and Drug Enforcement Administration number, if applicable, of practitioner;

8. (b) (b) Trade name, or generic name and manufacturer’s name, strength, dosage form, and quantity of drug dispensed; and

   1. (c) (c) Number of authorized refills, or if not refillable, it must be so indicated;

      1. (B) Must provide online retrieval, electronic record or hard copy, of refill history of each prescription order to include, in addition to information specified in this section but not limited to the following:

         1. (i) Initials or code designation of dispensing pharmacist for each refill;
         2. (ii) Date refilled; and
         3. (iii) Number of authorized refills remaining;

      2. (C) Daily prescription record. Must provide a daily prescription record, or hard copy printout of each day’s prescription order activity, to include but not limited to the following:

         1. (i) Date of record;
         2. (ii) Prescription order number, patient’s name, name of drug, quantity dispensed and dosage form of drug, practitioner’s name and Drug Enforcement Administration number, if applicable, and dispensing pharmacist’s designation or initials on each prescription;
         3. (iii)
9. (a) (a) If the pharmacy is using a hard copy printout, it may be replaced by monthly log containing the same information.

10. (b) (b) This information must be maintained at the pharmacy for a period of two (2) years;

    1. (iv) Any electronic data processing system must ensure strict confidentiality of patient records;

       1. (v) All required information must be entered on the records of all prescription orders filled at the pharmacy, including nonrefillable prescriptions, and must be maintained for a period of no fewer than two (2) years;

          1. (vi) Must be capable of producing a patient profile, electronic record or hard copy, indicating all drugs being taken and dates of refills for the patient;
          2. (vii)
11. (a) (a) A pharmacy shall make arrangements with a supplier of data processing services or materials to ensure continuing adequate and complete prescription orders and dispensing records.

12. (b) (b) If for any reason the relationship with said supplier terminates, the pharmacy shall ensure the continuity of records; and

    1. (viii)
13. (a) (a) The pharmacist-in-charge of the pharmacy shall maintain a bound log book in which each individual pharmacist or individual intern involved in dispensing of prescriptions shall sign a statement each day attesting to the fact that the prescription information entered into the computer that day has been reviewed by him or her and is correct as shown.

14. (b) (b) The log shall identify the time of day at which the pharmacist or intern:

    1. (1) (1) Started filling prescriptions; and

    2. (2) (2) Stopped filling prescriptions.

       1. (c) (c) Said log book shall be maintained by the pharmacist-in-charge or his or her successor in the pharmacy for a period of two (2) years after the date of dispensing the appropriately authorized prescription;

       2. (D) Must be capable of providing a refill-by-refill audit trail for any specific strength and dosage form of any drug in the system, to contain but not limited to the following:

          1. (i) Practitioner’s name;
          2. (ii) Name and address of patient;
          3. (iii) Name of drug (must include manufacturer’s name if generic name used);
          4. (iv) Quantity dispensed on original and each refill;
          5. (v) Prescription order number;
          6. (vi) Initials or code designation of dispensing pharmacist on original and each refill; and
          7. (vii) Date of original and each refill;

       3. (E)

          1. (i) If the pharmacy closes, it shall be the responsibility of the pharmacist-in-charge to ensure that all prescription records:
15. (a) (a) Are readily retrievable; and

16. (b) (b) Can be easily accessed.

    1. (ii) The pharmacist-in-charge:
17. (a) (a) At the date of closing, shall store said records; and

18. (b) (b) Within fourteen (14) days of closing, shall notify the board where said records are located.

    1. (iii) That pharmacist-in-charge shall ensure that a hard copy printout or a retrievable electronic record of any prescription records shall be produced and made available to:
19. (a) (a) A board representative on his or her request; and

20. (b) (b) Any other person authorized by law to examine or receive copies of prescription records.

    1. (iv) The records must be kept in a readily retrievable format for a period of two (2) years from the official closing date of the pharmacy;

       1. (F)

          1. (i) In the event of computer breakdown (down time), the pharmacy must have an approved auxiliary recordkeeping system.
          2. (ii) This system must contain all necessary information to ensure prompt data entry into the system as soon as the computer is available; and
       2. (G) If maintaining the Patient Daily Medication Record electronically, the data must be backed up at least daily, preferably continuously.
21. (f) In a pharmacy system that can delineate the individual steps in the prescription filling process, the pharmacist overseeing each step would be specifically responsible for that part of the process.
22. (g) In a system that is not capable of delineating the individual steps in the prescription filling process, the pharmacist or pharmacists involved in the process will share a corresponding liability for each prescription filled.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(10/09/80, Revised 6/19/97, 10/00, 3/14/2007 and 11/30/2010)."