201 KAR 2:170. Computerized recordkeeping.

      RELATES TO: KRS Chapters 217, 315

      STATUTORY AUTHORITY: KRS 217.215(2), 315.191(1), (5)

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.215(2) provides for the board to establish administrative regulations relating to the storage and retrieval of prescription records, including computerized recordkeeping. This administrative regulation will assure uniform compliance for those desiring to use computerized recordkeeping.

      Section 1. An automated data processing system may be used for the storage and retrieval of prescription information subject to the following conditions:

      (1) Written notification is provided to the Kentucky Board of Pharmacy that an automated data processing system is being utilized to maintain prescription records. Written notification must also be provided to the board that use of an automated data processing system is being discontinued.

      (2) All information pertinent to a prescription shall be entered into the system, including, but not limited to, each of the following:

      (a) The prescription number;

      (b) The patient's name and address;

      (c) The prescriber's name and address;

      (d) The prescriber's Federal Drug Enforcement Administration number, if appropriate;

      (e) Refill authorization;

      (f) Any prescriber's instructions or patient's preference permitted by law or administrative regulation;

      (g) The name, strength, dosage form, and quantity of the drug dispensed originally and upon each refill;

      (h) The date of dispensing of the prescription and the identifying designation of the dispensing pharmacist for the original filling and each refill.

      (3) The entries shall be made into the system at the time the prescription is first filled and at the time of each refill, except that the format of the record may be organized so that the information already entered may appear for the prescription or refill without reentering such information. The dispensing pharmacist is responsible for the completeness and accuracy of the entries. The original prescription order and a record of each refill shall be preserved by the pharmacy for a period of five (5) years and shall be subject to inspection by authorized agents. No original prescription order shall be obstructed in any manner.

      (4) The required information shall be entered into the system for all prescriptions filled at the pharmacy.

      (5) The system shall provide, within the pharmacy, retrieval of all required original and refill prescription information by display screen or hard-copy printout.

      (6) The system shall provide adequate safeguard against improper manipulation or alteration of the records.

      (7) The system shall have the capability of producing a hard-copy printout of all original and refilled prescription data as required in Section 1 of this administrative regulation. A hard-copy printout of the required data shall be made available to an authorized agent within forty-eight (48) hours of the receipt of a written request.

      (8) The system shall provide a hard-copy printout or log book of each day's prescription data. That printout or log book shall be verified, dated, and signed by the pharmacist(s) who filled such prescription orders. This document shall be maintained for a period of five (5) years. Permission to maintain an alternative system to produce this record may be granted by the board.

      (9) An auxiliary recordkeeping system shall be established for the documentation of refills if the automated data processing system is inoperative for any reason. The auxiliary system shall insure that all refills are authorized by the original prescription order and that the maximum number of refills is not exceeded. If the automated data processing system is restored to operation, the information regarding prescriptions filled and refilled during the inoperative period shall be entered into the automated data processing system within seventy-two (72) hours.

      (10) Controlled substance data contained on a hard-copy printout must be separated, asterisked, or in some other manner visually identifiable apart from other items appearing on the printout.

      (11) The pharmacist is responsible to assure continuity in the maintenance of records throughout any transition in record systems utilized.

      Section 2. A computer malfunction or data processing services provider's negligence is not defense against charges of improper recordkeeping.

      Section 3. This administrative regulation is not applicable to the recordkeeping for drugs prescribed for and administered to patients confined as inpatients in an acute care facility.

      Section 4. Violation of any provision of this administrative regulation constitutes unethical or unprofessional conduct in accordance with KRS 315.121. (9 Ky.R. 1264; Am. 10 Ky.R. 4; eff. 6-1-83.)