Kan. Admin. Regs. § 68-9-1 - Electronic data storage systems

All electronic data storage systems operating within this state shall comply with the following requirements:

Automated Prescription Systems

(a) The pharmacist in charge of such a system shall perform the following:

(1) Adopt a written policy and procedures manual for control, use, and operation of the system;

(2) assure that only licensed pharmacists make decisions concerning judgmental functions as stated in K.A.R. 68-2-20;

(3) be responsible for all drug information within the system;

(4) assure that complete control over the dispensing of medication is vested in licensed pharmacists;

(5) have an auxiliary procedure that shall be used for documentation of refills of all prescription orders if the system becomes inoperable. This auxiliary procedure shall insure that the following criteria are met:

(A) Refills are authorized by the original prescription order;

(B) the maximum number of refills has not been exceeded; and

(C) a daily backup is performed for use in restoring required information in case of a system failure;

(6) maintain a written prescription on file that preserves all information contained in the original prescription. A machine-printed supplement that provides all information necessary to comply with the law may be filed with or attached to the written prescription, if the supplement does not obscure the required information on the original prescription;

(7) provide a method of numerically identifying each patient's written prescription;

(8) maintain the confidentiality of prescriptions and assure that the system has adequate security and systems safeguards to prevent unauthorized access, modification, or manipulation of patient medication profile data; and

(9) maintain a written or electronic prescription daily log. The daily log shall include the following information:

(A) The original prescription number;

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

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

(D) the name and address of the practitioner;

(E) the practitioner's DEA registration number if required;

(F) the name, strength, dosage form, and quantity of the medication prescribed;

(G) the quantity dispensed, if different from the quantity prescribed; and

(H) the total number of refills authorized by the prescribing practitioner.

(b) Each electronic data storage system shall have a method for each of the following:

(1) Storing each active patient's medication profile record so that this record is immediately available upon request at the practice site. Sufficient historical patient medication profile data shall be stored and made available for the pharmacist to exercise appropriate clinical judgment when dispensing the prescription;

(2) documenting that an individual pharmacist has taken responsibility for the accuracy of the following:

(A) The information entered; and

(B) Each authorized refilling of the prescription;

(3) drug use control, which shall include the following:

(A) The ability to ascertain quantities;

(B) the exact refill data;

(C) the dates of previous refillings; and

(D) the number of refills remaining;

(4) identifying on a daily basis the pharmacist filling each prescription;

(5) handling partial fillings and refillings of prescriptions;

(6) handling compounded prescriptions;

(7) reproducing all information within the system, in written form and upon authorized request, within 72 hours; and

(8) providing a label containing the information required under K.A.R. 68-7-14 and the date of the original filling of any scheduled drugs.

Notes

Kan. Admin. Regs. § 68-9-1

Authorized by K.S.A. 65-1630 and K.S.A. 2001 Supp. 65-4102; implementing K.S.A. 2001 Supp. 65-1626(t), K.S.A. 2001 Supp. 65-1642, and K.S.A. 65-4121; effective May 1, 1980; amended May 1, 1989; amended April 3, 1990; amended Sept. 9, 1991; amended March 22, 2002.