201 KAR 2:170.
RELATES TO: KRS 217.215, 217.216, 315.191
STATUTORY AUTHORITY: KRS 217.215(2),
NECESSITY, FUNCTION, AND CONFORMITY: KRS
217.215(2) provides for the board to establish administrative regulations
relating to the storage and retrieval of prescriptions records, including
computerized recordkeeping. This administrative regulation provides standards
for those desiring to use computerized recordkeeping.
Section 1. The following information
shall be entered into the system:
(1) 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; and
(h) The date of dispensing of the
prescription and the identifying designation of the dispensing pharmacist for
the original filling and each refill.
(2) 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 data already
entered may appear for the prescription or refill without reentering that data.
Records that are received or sent electronically may be kept electronically. The
dispensing pharmacist shall be responsible for the completeness and accuracy of
(3) The original prescription and a
record of each refill, if received written or oral, shall be preserved as a
hard copy for a period of three (3) years and thereafter be preserved as a hard
copy or electronically for no less than an additional two (2) years. The original
prescription and a record of each refill, if received by facsimile, shall be
preserved as a hard copy, the original electronic image, or electronically for
a period of three (3) years and thereafter be preserved as a hard copy, the
original electronic image, or electronically for no less than an additional two
(2) years. The original and electronic prescription shall be subject to
inspection by authorized agents. An original prescription shall not be
obstructed in any manner.
(4) The original prescription and a
record of each refill, if received as an e-prescription, shall be preserved
electronically for a period of no less than five (5) years. The electronic prescription
shall be subject to inspection by authorized agents. An original prescription
shall not may be obstructed in any manner.
(5) The required information shall be
entered into the system for all prescriptions filled at the pharmacy.
(6) The system shall provide adequate
safeguards against improper manipulation or alteration of the data.
(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 maintain a record of
each day’s prescription data as follows:
(a) This record shall be verified, dated,
and signed by the pharmacist(s) who filled those prescription orders either:
2. Manually; or
3. In a log.
(b) This record shall be maintained for
no less than five (5) years; and
(c) This record shall be readily
retrievable and shall be subject to inspection by authorized agents.
(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 shall be
identifiable apart from other items appearing in the record.
(11) The pharmacist shall be 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 shall not be not a 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.
(9 Ky.R. 1264; Am. 10 Ky.R. 4; eff. 6-1-1983; 38 Ky.R. 652; 1297; eff. 1-18-2012.)