Electronic Record-Keeping Systems

PURPOSE: The purpose of this rule is to establish requirements and guidelines for maintaining prescription hard copies in an electronic record-keeping system. (1) In lieu of maintaining the original prescription hard copy or a hard copy representation as required by 20 CSR 2220-2.018 or 20 CSR 2220-2.080, a pharmacy shall be authorized to maintain an exact digitized image of the prescription in an electronic recordkeeping system (ERS). For purposes of this rule, an electronic record-keeping system is defined as a system maintained by the pharmacy that provides input, storage, processing, communications, output, and control functions for digitized images of original prescriptions. Any alterations to the digitized original prescription shall be documented as required by 20 CSR 2220-2.018 or 20 CSR 2220-2.080, as applicable. (2) Controlled substance hard copy prescriptions shall be maintained as required by applicable state and federal law. (3) Digitized prescription images shall be readily retrievable by the pharmacy. Readily retrievable shall be defined as providing records immediately or within two (2) hours of a request of the inspector or by making a computer terminal available to the inspector for immediate use. An ERS system shall be capable of printing and retrieving the digitized prescription image at the time of inspection, including the reverse side of the prescription if applicable. Any printout of a digitized prescription image provided by a licensee/ registrant to the patient or the patient’s representative shall be conspicuously marked with the statement “Copy Only – Not Valid for Dispensing Purposes.” (4) Pharmacies maintaining an ERS shall establish written policies and procedures for the use of the ERS which shall include policies and procedures for reviewing compliance with the requirements of this rule and for storing, retrieving, and recovering digitized images. The policy and procedure manual shall be reviewed annually and shall be available to representatives of the board upon request. (5) All digitized images in the ERS shall be stored, copied, or saved onto secure storage media on a regular basis in a manner that will allow image recovery in the event of a disaster, system interruption, or system failure. AUTHORITY: sections 338.100 and 338.140, RSMo Supp. 2012.* Original rule filed Jan. 10, 2013, effective Aug. 30, 2013. *Original authority: 338.100, RSMo 1939, amended 1971, 1990, 1997, 1999, 2010 and 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011.