Kan. Admin. Regs. § 68-7-8 - Records
(a) Each of the
following terms, as used in this regulation, shall have the meaning specified
in this subsection:
(1) "Digital image" means
the electronic record produced when a hard-copy prescription is scanned by a
computer and converted from human-readable format to a computer-readable
digital format and maintained as part of the prescription record in a pharmacy
prescription application.
(2)
"Electronic annotation" means a method to mark up a digital image or electronic
prescription to allow both notes and clarifications to be added to the
prescription record without altering the original digital
image.
(b) Each pharmacy
owner and pharmacist-in-charge shall keep a book or file that records every
prescription order filled at the pharmacy.
(c)
(1) A
digital image of the prescription may constitute the original prescription
order. A hard copy of the prescription order shall not be required to be
maintained if all of the following conditions are met:
(A) The prescription is not for a controlled
substance.
(B) The pharmacy
prescription application can capture and store an exact and legible image of
the original prescription.
(C) The
digital image includes the front and back of the prescription and retains all
colors and graphics on the prescription.
(D) The digital image is
unalterable.
(E) The digital image
and all electronic annotations are readily retrievable and can be immediately
reproduced by the pharmacy prescription application in electronically viewable
and paper formats. In lieu of reproducing the digital image in a color paper
format, the digital image may be provided in color in an electronic portable
document format (PDF).
(F) Policies
and procedures for the use of digital images are developed and implemented to
include capturing, making, storing, retrieving, and recovering digital images
and electronic annotations, and destruction of the original hard-copy
prescription.
(G) The pharmacy
maintains a back-up copy of the digital image and all electronic annotations
stored in the pharmacy prescription application and updates the back-up copy at
least once every seven days.
(H) A
secure destruction method is used to dispose of the hard-copy prescription to
ensure privacy and confidentiality.
(2) If the pharmacy prescription application
data is automatically entered by a prescription order received by electronic
transmission, the automated record shall constitute the original prescription
order and a hard copy shall not be required if all of the following conditions
are met:
(A) The electronic prescription and
its means of transmission meet all requirements of the pharmacy act of the
state of Kansas and the state and federal controlled substance acts, and
amendments thereto.
(B) The
pharmacy prescription application can capture and store all prescription
information received.
(C) The
prescription information is readily retrievable, and the pharmacy prescription
application can immediately reproduce all prescription information received in
both electronically viewable and paper formats.
(D) The pharmacy maintains a back-up copy of
the electronic prescription record and all electronic annotations stored in the
pharmacy prescription application and updates the back-up copy at least once
every seven days.
(3)
Nothing in paragraph (c)(1) shall be construed as requiring a pharmacy to
maintain a digital image in lieu of hard-copy prescription.
(d) Any digital image may contain electronic
annotations if the original image is still available for review and the name of
the individual who made the annotations is documented.
(e) The pharmacist shall ensure that each
printout of a digital image provided to a patient or the patient's
representative is conspicuously marked "Copy Only" or "Not Valid for Dispensing
Purposes."
(f) Each pharmacy owner
shall establish policies and procedures in accordance with this regulation and
shall ensure that all policies and procedures comply with the pharmacy act of
the state of Kansas, and amendments thereto, and the implementing regulations.
Each pharmacist-in-charge shall document an annual review of the policies and
procedures for compliance with the pharmacy act, and amendments thereto, and
the implementing regulations.
(g)
Each of the following individuals shall be responsible for ensuring that each
digital image is a complete, accurate, and legible representation of the
corresponding hard-copy prescription:
(1) The
pharmacist, pharmacist intern, or pharmacy technician who generates the digital
image;
(2) the pharmacist,
pharmacist intern, or pharmacy technician who enters the prescription
information into the pharmacy prescription application; and
(3) the pharmacist who verifies the
prescription.
Notes
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