Kan. Admin. Regs. § 68-7-21 - Institutional drug rooms

(a) All prescription-only drugs dispensed or administered from an institutional drug room shall be in prepackaged units, the original manufacturer's bulk packaging, or patient-specific pharmacy labeled packaging. All prepackaging shall meet the requirements of K.A.R. 68-7-15.

(b) Each pharmacist or practitioner, as that term is defined in K.S.A. 65-1637a and amendments thereto, who is responsible for supervising an institutional drug room shall perform the following:

(1) Develop or approve programs for the training and supervision of all personnel in the providing and control of drugs;

(2) develop or approve a written manual of policies and procedures governing the storage, control, and provision of drugs when a pharmacist or practitioner is not on duty;

(3) maintain documentation of at least quarterly reviews of drug records, drug storage conditions, and the drugs stored in all locations within the institutional drug room;

(4) develop or approve written procedures for maintaining records of the provision and prepackaging of drugs; and

(5) develop or approve written procedures for documenting all reportable incidents, as defined in K.A.R. 68-7-12b, and documenting the steps taken to avoid a repeat of each reportable incident.

(c) The policies and procedures governing the storage, control, and provision of drugs in an institutional drug room when a pharmacist or practitioner is not on duty shall include the following requirements:

(1) A record of all drugs provided to each patient from the institutional drug room shall be maintained in the patient's file and shall include the practitioner's order or written protocol.

(2) If the practitioner's order was given orally, electronically, or by telephone, the order shall be recorded, either manually or electronically. The recorded copy of the order shall include the name of the person who created the recorded copy and shall be maintained as part of the permanent patient file.

(3) The records maintained in each patient's file shall include the following information:

(A) The full name of the patient;

(B) the date on which the drug was provided;

(C) the name of the drug, the quantity provided, and strength of the drug provided;

(D) the directions for use of the drug; and

(E) the prescriber's name and, if the prescriber is a physician's assistant or advanced registered nurse practitioner, the name of that person's supervising practitioner.

(d) All drugs dispensed from an institutional drug room for use outside the institution shall be in a container or package that contains a label bearing the following information:

(1) The patient's name;

(2) the identification number assigned to the drug provided;

(3) the brand name or corresponding generic name of the drug, the strength of the drug, and either the name of the manufacturer or an easily identified abbreviation of the manufacturer's name;

(4) any necessary auxiliary labels and storage instructions;

(5) the beyond-use date of the drug provided;

(6) the instructions for use; and

(7) the name of the institutional drug room.

(e) Each label for any prepackaged or repackaged drug shall meet the requirements of K.A.R. 68-7-16.

Notes

Kan. Admin. Regs. § 68-7-21

Authorized by K.S.A. 65-1630 and K.S.A. 65-1637a; implementing K.S.A. 2008 Supp. 65-1626, K.S.A. 2008 Supp. 65-1626d, and K.S.A. 65-1637a; effective April 23, 2010.