Volume 43 - Issue 31 - August 1, 2024

State of Kansas

Board of Pharmacy

Permanent Administrative Regulations

Article 2.—DRUGSTORES

68-2-5. (Authorized by K.S.A. 65-1630; implementing K.S.A. 2019 Supp. 65-1626, K.S.A. 65-1637c, and K.S.A. 65-1643; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended May 1, 1978; amended May 1, 1988; amended Aug. 1, 1997; amended March 22, 2002; amended Feb. 7, 2020; revoked Aug. 16, 2024.)

68-2-25. Minimum requirements of a prescription for a non-controlled substance. (a) Each pharmacist shall ensure the following requirements are met before dispensing each prescription for a non-controlled substance. The prescription shall:

(1) Contain, at a minimum, the following information:

(A) date the prescription is issued;

(B) name of the prescriber;

(C) signature of the prescriber, if required by K.S.A. § 65-1637 and amendments thereto;

(D) first and last name of the patient;

(E) drug name;

(F) quantity prescribed;

(G) directions for use;

(H) first and last name of the agent of the prescriber if the prescription is transmitted by a person other than the prescriber; and

(2) Contain the name or initials of the pharmacist, or pharmacist intern, receiving the prescription if the prescription is received verbally.

(b) The pharmacist shall document any additions, changes, corrections, or updates made to the prescription on the prescription or in the prescription record as a result of any:

(1) Consultation with the prescriber or the prescriber’s agent; or

(2) adaptation as authorized by K.S.A. 65-1637(g)(3) and amendments thereto.

(c) All records and documentation required by this regulation shall be maintained and readily retrievable for a period of five years. (Authorized by K.S.A. 65-1630 and K.S.A. 65-1656; implementing K.S.A. 65-1637, K.S.A. 65-1637d, K.S.A. 65-1642, and K.S.A. 65-1657; effective Aug. 16, 2024.)

Article 7.—MISCELLANEOUS PROVISIONS

68-7-18. Health departments, private not-for-profit family planning clinics, federally qualified health centers, and indigent healthcare clinics. The supply and control of drugs provided by health departments, private not-for-profit family planning clinics, federally qualified health centers, and indigent healthcare clinics authorized under K.S.A. 65-1648(d)(1), and amendments thereto, shall conform to the following requirements:

(a) The approved drugs that may be stored and supplied by health departments, not-for-profit family planning clinics, and indigent healthcare clinics shall be only noncontrolled drugs that are approved by the food and drug administration.

(b) The approved drugs that may be stored and supplied by a federally qualified health center shall be only drugs that are approved by the food and drug administration.

(c)(1) The pharmacist-in-charge shall ensure that health departments, family planning clinics, federally qualified health centers, and indigent healthcare clinics maintain and implement written policies and procedures for the following:

(A) Supervision of all personnel in the supply and control of drugs;

(B) storage, control, supply, labeling, and prepacking of drugs;

(C) documentation of at least quarterly checks of drug records, drug storage conditions, and drugs stored in all locations within the facility by a pharmacist;

(D) drug recall procedure that can be effectively implemented; and

(E) maintaining records of supplying and prepacking of drugs.

(2) Drugs packaged in advance of immediate need shall meet the requirements of K.A.R. 68-7-15 and 68-7-16.

(d) The procedures for the control and supplying of drugs within health department facilities, family planning clinics, federally qualified health centers, and indigent healthcare clinics shall be consistent with the following requirements:

(1) Adequate records of the drugs supplied by the designated registered professional nurse or nurses shall be maintained and shall include the prescriber’s order or written protocol.

(A) If the prescriber’s order was given verbally, the designated registered professional nurse or nurses shall reduce that order to writing. The written copy of the order shall be maintained in a permanent patient file.

(B) The records shall include the following:

(i) The full name of the patient;

(ii) the date ordered;

(iii) the name of the drug, strength, and the quantity supplied;

(iv) the directions for use;

(v) the prescriber’s name and the name of the supervising physician if the prescriber is a physician’s assistant; and

(vi) if the order is received verbally, the first and last name of the registered professional nurse that received that order.

(C) The following shall be recorded in a log or accessible in a searchable database:

(i) The full name of the patient;

(ii) the name of the drug, strength, and quantity supplied;

(iii) the date supplied;

(iv) the internal ID number assigned to the supply of the drug provided.

(2) A supply of drugs shall be provided to a patient by a designated registered professional nurse or nurses pursuant to a prescriber’s order. Only a designated registered professional nurse or nurses may access the pharmacy area and remove the supply of the drugs. The supply shall conform with the labeling requirements of K.A.R. 68-7-14.

(e) The designation of a pharmacist-in-charge of a health department, family planning clinic, federally qualified health center, or indigent healthcare clinic shall be subject to the provisions of K.A.R. 68-1-2a and 68-7-13. (Authorized by and implementing K.S.A. 65-1648; effective, T-84-3, Feb. 10, 1983; effective May 1, 1984; amended July 23, 1999; amended April 28, 2000; amended Aug. 16, 2024.)

Article 19.—CONTINUOUS QUALITY ASSURANCE PROGRAMS

68-19-1. Minimum program requirements. Each pharmacy’s continuous quality improvement program shall meet the following minimum requirements:

(a) The pharmacist-in-charge or the pharmacist-in-charge’s designee shall start reviewing each incident report within seven days, and the pharmacist-in-charge shall complete the review of each incident report within 30 days of the incident report’s creation. The pharmacist-in-charge shall document and perform the following as part of the review process:

(1) Communicate with each employee involved in the incident;

(2) complete a root cause analysis of the incident report; and

(3) create a corrective action plan for the incident.

(b) No later than the 15th day of each February, April, June, August, October, and December, the pharmacist-in-charge shall create a summary and communicate the information from the summary to each licensee and registrant under the pharmacist-in-charge’s supervision. The summary shall include the following information from the two previous calendar months:

(1) Each type of incident reported, including each identified prescription number involved;

(2) each root cause analysis completed;

(3) each corrective action plan created; and

(4) evaluation of the outcomes and effectiveness of each correction action plan from the monthly summaries for the previous four months.

If the pharmacy did not have any new incident report, root cause analysis, or corrective action plan since the last summary, the pharmacist-in-charge shall create a null report. “Null report” means a report that states that the pharmacy did not have any new incident reports, root cause analyses, or corrective action plans.

(c) The pharmacy shall maintain a copy of each summary and null report in a readily retrievable format for a period of at least five years.

(d) Any pharmacy that actively reports to a patient safety organization certified by the secretary pursuant to 42 U.S.C. § 299b-24, and amendments thereto, that has a primary mission of continuous quality improvement, shall be exempt from the requirements set forth in paragraphs (a)(2), (a)(3), (b)(2), and (b)(3) of this regulation. The pharmacy shall maintain a record of the pharmacy’s membership with the patient safety organization in a readily retrievable format for a period of five years. (Authorized by and implementing K.S.A. 65-1695; effective April 10, 2009; amended Nov. 29, 2019; amended Aug. 16, 2024.)

Alexandra Blasi
Executive Secretary
Board of Pharmacy

Doc. No. 052369