Section 856IAC5-1-6. Written policies and procedures of operation

   (a) An automated medication system used to fill prescriptions or medication orders shall be operated according to the pharmacy's or facility's written policies and procedures of operation. The policies and procedures of operation shall:

(1) include a:

(A) table of contents; and

(B) description of all procedures of operation;

(2) set forth methods that record any revision of the policies and procedures for a minimum of two (2) years from the date of the revision. Any such revision must be approved by the qualifying pharmacist or practitioner by handwritten signature and date;

(3) set forth methods that ensure that a pharmacist currently licensed in the transmitting jurisdiction reviews and approves the transmission of each original or new prescription or medication order to the automated medication system before the transmission is made;

(4) set forth methods to protect patient confidentiality as required by state and federal law;

(5) set forth methods that ensure access to the system is limited to approved personnel with accountability for all access to the system; and

(6) identify the circumstances under which medications may be removed from the automated medication system by a licensed practitioner for distribution to a patient without prior order review by a registered pharmacist.

  (b) A pharmacy or facility that uses an automated medication system to fill prescriptions or medication orders shall annually review its written policies and procedures of operation and revise them if necessary.

  (c) A copy of the written policies and procedures of operation adopted under this section shall be retained at the pharmacy or facility where the automated medication system is utilized. The pharmacy or facility shall provide to the board a copy of the written policies and procedures of operation for inspection and review upon request by the board. (Indiana Board of Pharmacy; 856 IAC 5-1-6; filed Nov 21, 2007, 12:04 p.m.: 20071219-IR-856070590FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA)