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.
   2. (2) 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 of this part are declared severable.
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 shall be performed by a pharmacist or pharmacy technician.
   2. (2) The final verification of prescription information entered 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)

   1. (1) An electronic data processing system:

      1. (A) Must be readily accessible electronically online or by hard copy; and
      2. (B) Shall be capable of printing a hard copy record.
   2. (2) The 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)

5. (i) Patient Medication Profile, accessible electronically online or by hard copy.

   1. (ii) Definition. As used in this part, “Patient Medication Profile” means the basic document used by the hospital pharmacist to monitor a patient’s:
6. (a) (a) Medication regimen;

7. (b) (b) Drug compliance;

   1. (c) (c) Drug interactions;

      1. (d) (d) Allergies; and

8. (e) (e) Drug usage.

   1. (iii) The Patient Medication Profile must contain, at a minimum, the following:
9. (a) (a) Patient name, patient identification number, practitioner’s name, drug name, drug strength and dosage form, number of doses issued, initials, name or identification number of pharmacist approving original order into the system, and date original order was entered into the system; and

10. (b) (b) The Final Patient Medication Profile must be maintained by the pharmacy;

    1. (B) Patient Daily Medication Record.

       1. (i) The Patient Daily Medication Record is a document, whether electronic or hardcopy, which supports the Patient Medication Profile.

          1. (ii) The Patient Daily Medication Record provides a daily refill-by-refill audit trail on all drugs dispensed and supplements the base document, the Patient Medication Profile.
          2. (iii)
11. (a) (a) This record is produced on a daily basis.

12. (b) (b) It may be used to fill patient medication orders for transport to the patient care area.

    1. (c) (c) This record must show all medications dispensed on any given day.

       1. (iv) The Patient Daily Medication Record must contain, at a minimum, the following:
13. (a) (a) Date of record;

14. (b) (b) Patient name;

    1. (c) (c) Patient identification number;

       1. (d) (d) Drug name;
15. (e) (e) Drug strength and dosage form; and

16. (f) (f) Number of doses issued on that day.

    1. (v)
17. (a) (a) The initials of the pharmacist who checked and verified the doses dispensed must appear on the Patient Daily Medication Record if not shown on the Patient Medication Profile described in this section.

18. (b) (b) Since the Patient Daily Medication Record supports the Patient Medication Profile, some information such as practitioner’s name, initials, name or identification number of pharmacist entering the original order into the system, and the date of the original order may or may not be duplicated because the information is readily retrievable from the base document.

    1. (vi)
19. (a) (a) The Patient Daily Medication Record must be kept and a bound log book must be signed by all pharmacists filling orders for that day.

20. (b)

    1. (1) (b)(1) If a printed hard copy is used, the printout may be replaced by a monthly log containing the same information.

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

       1. (vii)

21. (a) (a) The pharmacist-in-charge of the hospital pharmacy will maintain a bound log book in which each individual pharmacist and intern involved in the dispensing of medications will sign the log book each day, attesting to the fact that the prescription information entered into the computer that day:

    1. (1) (1) Has been reviewed by him or her; and
    2. (2) (2) Is correct as shown.

22. (b) (b) The log shall identify the time of day at which the pharmacist started filling and stopped filling prescriptions.

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

       1. (C) Ensure strict confidentiality of all patient records;

       2. (D)

          1. (i) If the hospital pharmacy closes, the pharmacist-in-charge:
23. (a) (a) At the date of closing shall store said records; and

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

    1. (ii) A hard copy printout or electronic database of any daily log or logs shall be produced and made available to:
25. (a) (a) A board representative on their request; and

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

    1. (E) If maintaining the Patient Daily Medication Report electronically, the data must be backed up at least daily, preferably continuously.

27. (e)

    1. (1) Hospital pharmacies that make arrangements with outside suppliers of data processing services or materials must assure themselves of continuing, adequate, and complete drug information data and issuing records.
    2. (2) If for any reason the relationship with said supplier terminates, the pharmacy shall ensure the continuity of records.

28. (f)

    1. (1) In the event of computer breakdown (down time), the pharmacy must have an auxiliary recordkeeping system.
    2. (2) The backup system must contain all necessary information to ensure prompt data entry into the system as soon as the computer is again available.
29. (g) Registrants holding a hospital pharmaceutical services permit who fill outpatient prescriptions and who wish to utilize electronic data processing equipment as a recordkeeping system must then comply with all the requirements of 17 CAR § 160-1206.
30. (h) The electronic data processing systems described in this part are acceptable as the disposition records for all drugs, except that the actual signed disposition (proof of use) records for Schedule II controlled substances must be retained separate from other records for a period of two (2) years.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “10/09/80(Revised 6/15/95, 6/19/97, & 10/11/2000)"