201 KAR 2:170.

Computerized recordkeeping.

 

      RELATES TO: KRS 217.215, 217.216, 315.191

      STATUTORY AUTHORITY: KRS 217.215(2),

315.191(1),(a), (f)

      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

the entries.

      (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:

      1. Electronically;

      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.)