Kan. Admin. Regs. § 68-20-18a

Current through Register Vol. 43, No. 46, November 14, 2024

Section 68-20-18a - Information concerning prescriptions; recordkeeping; pharmacy prescription application

(a) Each controlled substance shall be supplied or dispensed directly to a patient only pursuant to a prescription issued in accordance with K.A.R. 68-20-18. Each controlled substance shall be supplied at a registered facility for immediate facility administration to the ultimate user only pursuant to a medication order.

(b) Each dispensing, partial filling, or refilling of a prescription for a controlled substance shall be entered on the back of the prescription with the date, quantity, and name or initials of the pharmacist providing the final verification.

(c) As an alternative to the procedures provided by subsection (b), a pharmacy prescription application may be used for the storage and retrieval of dispensing, refill, and partial filling information for prescription orders for controlled substances if all of the following requirements are met:

(1) Each computerized system shall provide on-line retrieval, by computer monitor display or hard-copy printout, of original prescription order, refill, and partial fill information for those prescription orders that are authorized for filling. Each display or printout of information shall include the following:

(A) The original prescription number;

(B) the date of issuance of the original prescription order by the prescriber;

(C) the dates of dispensing or partial filling;

(D) the full name and address of the patient;

(E) the name, address, and DEA registration number of the prescriber;

(F) the name, strength, dosage form, quantity of the controlled substance prescribed, and the quantity dispensed, if different from the quantity prescribed;

(G) the identification code, or name or initials of the dispensing pharmacist;

(H) the total number of refills authorized by the prescriber, if applicable and allowable; and

(I) the total number of doses dispensed to date for that prescription order.

(2) Each pharmacist who makes use of a pharmacy prescription application shall document that the information in the pharmacy prescription application is correct each time the pharmacist fills, refills, or partially fills a controlled substance.

(A) If the pharmacy prescription application produces a hard-copy printout of each day's controlled substance prescription order data, the printout shall meet the following requirements:

(i) The printout shall be verified, dated, and signed by the pharmacist who filled or partially filled the prescription order. The pharmacist shall verify that the date indicated is correct and then sign this document in the same manner as the pharmacist would sign a check or legal document.

(ii) The printout shall be provided to each pharmacy using the computerized system within 72 hours of the date on which the controlled substance was dispensed.

(iii) The printout shall be verified and signed by each pharmacist who is involved in the dispensing.

(B) In lieu of signing a hard-copy printout of each day's controlled substance prescription order data, the pharmacy owner shall maintain a bound logbook or separate file in which each pharmacist involved in the dispensing shall sign a statement, in the manner described in paragraph (c)(2)(A), each day, attesting to the fact that the information entered into the pharmacy prescription application that day has been reviewed by the pharmacist and is correct as shown.

(3) Each pharmacy prescription application shall have the capability of producing a printout of any fill data that the facility is responsible for maintaining. Each printout shall include an audit trail for any specified strength and dosage form of any controlled substance, by brand, generic name, or both, in addition to the following:

(A) The name of the prescriber;

(B) the name and address of the patient;

(C) the quantity dispensed on each fill;

(D) the date of dispensing of each fill;

(E) the name or identification code of the dispensing pharmacist; and

(F) the number of the original prescription order.

(4) If a pharmacy experiences a computer system outage of the pharmacy prescription application, the pharmacy shall have an auxiliary procedure that will be used for documentation of partial fills and refills of controlled substance prescriptions. This auxiliary procedure shall ensure that partial fills or refills are authorized by the original prescription, the maximum number of dosage units or refills has not been exceeded, the prescription is still valid for partial filling or refilling, and all appropriate data is retained for on-line data entry as soon as the computer system is available for use again.

(d) All prescriptions, records, and documents required by this article of the board's regulations shall be kept readily retrievable at the registered location for five years from the date of the last filling, refilling, partial filling, or entry into the record, except that financial and shipping records may be kept at other than the registered location with approval of the DEA.

Kan. Admin. Regs. § 68-20-18a

Authorized by and implementing K.S.A. 65-4102, K.S.A. 65-4121, and K.S.A. 65-4123; adopted by Kansas Register Volume 42, No. 20; effective 6/2/2023.