20 CSR 2220-2.083 - 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 record-keeping
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.
Notes
*Original authority: 338.100, RSMo 1939, amended 1971, 1990, 1997, 1999, 2010 and 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011 .
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